TRULY POLYAXIAL, SOLID AND POWERFUL

Transcription

1 S U R G I C A L T E C H N I Q U E V2 TRULY POLYAXIAL, SOLID AND POWERFUL P O L Y A X I A L S P I N E S Y S T E M a decade of results

2 P O L Y A X I A L S P I N E S Y S T E M TRULY POLYAXIAL, SOLID AND POWERFUL POLYAXIALITY STABILITY EFFICIENCY All the implants offer the Polyaxiality, including Hooks, Claws, Sacral Plates and of course Pedicle screws. Exclusive Polyaxial Claw system for thoracic anchorage, excellent bone thread for pedicle screws, left and right anatomical sacral plates using screws crossed in the 3 dimensions. Ease of rod connection due to the Polyaxiality and Stability of all implants, friendly user instrumentation.

3 INSTRUMENTATION A Squared awl reamer shaft A Straight threaded awl shaft A Squared awl shaft A Straight spatula A Curved spatula A Bone probe A Pedicle screwdriver shaft A Rod pusher shaft A Tap for ø 4.5 mm pedicle screw A Tap for ø 5.5 mm pedicle screw A Tap for ø 6.5 mm pedicle screw A Tap for ø 7.2 mm pedicle screw A Rod rotating wrench 0 shaft A ,5 mm Hexagonal Screwdriver shaft A Selfholding nutdriver and breaker A Nut driver shaft for final tightening A T20 Screwdriver A mm Hex hollow nutdriver shaft A Right in situ bender A Left in situ bender A Straight ratchet handle for shafts A T ratchet handle for shafts A Malleable rod, length 150mm A Malleable rod, length 350mm A Palm ratchet handle for shafts A Depth gauge A Rod holder A French bender A Compressor A Set of jaws for compressor A A Rod spreader A Set of jaws for spreader A

4 A Set of L-JAWS A Countertorque MS 209 Templates set for rod plates MS 214 Nutdriver and positionner for plate and rod MS 219 Pedicle probe MS 227 Connecting clamp releaser MS 502 Hook inserter set MS 503 Hook holder MS 504 Pedicle hook starter MS 505 Laminar and transverse process hook starter MS 507 Compressor forceps for claw MS 510 Flexible nutdriver for claw MS 511 Rod gripper MS 512 Hex. positionner wrench for claw MS 513 Double end wrench for claw nut MS 514 Flexible guiding tube MS 515 Ratcheting wrench for claw nut MS 524 Handle for sacral plate drill guide MS 525 Drill guide for sacral plate MS250 Complete empty trays displaying set for implants A Case for PASS instruments A PASS deformity case MS64102 Stylet with 2.5 mm Hexagon for Crosslink System

5 S U R G I C A L T E C H N I Q U E PASSmed (Polyaxial Spine System) is the result of collaboration between a group of spine surgeons and Medicrea since The Polyaxial Spine System facilitates spinal osteosynthesis for various deformities in the Thoraco-Lumbar or Lumbo-Sacral area. PASSmed implants are made of Titanium (Ti-6A1-4v Eli), produce a solid construct and are user friendly. SUMMARY insertion of vertebral anchors screw Fixation 1 1. Lumbar Spine Thoracic Spine... 9 insertion of vertebral anchors Claw Fixation 2 1. Thoracic fixation using a pediculo/transverse claw Thoracic fixation using a pediculo/laminar claw Lumbar fixation using a lamino/laminar claw fixation using a sacral plate 3 1. Insertion of the S1 screw Insertion of the bicortical inferior screw into the sacrum ala rod-plate construct 4 Rod-plate construct rod construct 5 Rod Construct rod to rod linkage 6 1. Transverse link Crosslink system reduction of the deformity 7 Reduction of the deformity

6 P O L Y A X I A L S P I N E S Y S T E M insertion of vertebral anchors screw Fixation 1 The PASSmed polyaxial screws are available in different diameters and lengths. Each diameter is color-coded: Purple for 4.5 mm Dia., green for 5.5 mm Dia., blue for 6.5 mm Dia., gold for 7.2 mm Dia. and grey for larger Dia. screws. Ø (mm): 4,5 5,5 6,5 7,2 8 The 4.5 mm PASSmed pedicle screws should be used in the thoracic spine ONLY. PASSmed 5.5 mm screws should be reserved for the upper lumbar spine (L1, L2 and L3). PASSmed 6.5 mm screws should be reserved for the lower lumbar spine (L4 and L5). Similarly, PASSmed 7.2 mm screws (or larger diameter screws) should be reserved for the sacral spine or for revision surgery. The height of the screw seating can be adjusted using Polyaxial Offset screws with a 3 mm or 6 mm offset. This will provide optimal alignment of the screw heads in the sagittal plane and/or compensation for bone loss (if any). 1. LUMBAR SPINE Facetectomy: resection of the inferior articular process of the overlying vertebra using a gouge chisel. Preparation of the implantation site: Decortication of the superior articular process of the instrumented vertebra using a rongeur. 6

7 S U R G I C A L T E C H N I Q U E Location of the pedicle entry point and creation of a pilot hole with the Squared awl (A ): this hole is usually located at the intersection of a horizontal line which bisects the transverse process and a vertical line through the middle of the superior articular process. IMPORTANT: For the superior end of the instrumentation, be sure to secure the screw position outside of the facet joint. Preparation of the pathway using the Curved spatula (A ) (or the Bone probe A ), with the concave surface of the instrument facing the spinal canal. NOTE: The Straight threaded awl (A ) can also be used to prepare the pedicule pathway. Test the pathway with the Pedicle probe (MS219). This pedicle feeler is used to check that the pedicle wall has not been breached. 7

8 P O L Y A X I A L S P I N E S Y S T E M insertion of vertebral anchors screw Fixation 1 Enlargement of the hole with a curette and retesting with the Pedicle probe (MS219). NOTE : In case of hard bone, it can be useful to use one of the taps (A , A , A or A according to the screw diameter to be implanted), to prepare the pedicle screw insertion. Taps diameters are undersized by 0.5mm. Preparation of the screw seating: in some cases a Pedicle reamer (A ) will be used for levelling the area that will accommodate the screw head. This is accomplished by hand, using a rotary motion. NOTE: For a rod-plate construct used only in Lumbar area, a set of templates (MS 209) is available to help determine the appropriate rodplate size. Insert two pins into the prepared pedicles; a template is selected such that it goes over these two pins. This corresponds to the appropriate rod-plate size. 8

9 S U R G I C A L T E C H N I Q U E Insertion of the screw with the Pedicle screwdriver (A ). 2. THORACIC SPINE Facetectomy: resection of the inferior articular process of the overlying vertebra using a gouge chisel. Preparation of the implantation site: Decortication of both the transverse process and the base of the articular process of the instrumented vertebra using a rongeur. 9

10 P O L Y A X I A L S P I N E S Y S T E M insertion of vertebral anchors screw Fixation 1 Location of the pedicle entry point and creation of a pilot hole using the awl (A ): this hole is usually located at the intersection of a horizontal line which runs through the upper third of the transverse process and a vertical line through the middle of the articular process. Preparation of the pathway using the Curved spatula (A ) (or the Bone probe A ), with the concave surface of the instrument facing the spinal canal (see figure p.7). NOTE: The Straight threaded awl (A ) can also be used to prepare the pedicule pathway. Test the pathway with the pedicle probe (MS219). This pedicle feeler is used to check that the pedicle wall has not been breached (see figure p.8). Enlargement of the hole with a curette and retesting with the pedicle probe (MS219) (see figure p.8). NOTE: In case of hard bone, WHILE TAKING PRECAUTION, it can be useful to use one of the taps to prepare the pedicle screw insertion (see figure p. 8). Taps diameters are undersized by 0.5mm. Insertion of the screw with the pedicle screwdriver (A ) (see figure p.9). IMPORTANT: The use of an image intensifier (C-arm) is highly recommended for per-operative control of pedicle screw placement. Alternatively, a surgical navigation system can be used. 10

11 S U R G I C A L T E C H N I Q U E insertion of vertebral anchors Claw Fixation 2 The claw consists of two hooks facing each other, one main polyaxial hook and one counterhook which closes the claw. There are several types of claws according to the levels instrumented, lumbar or thoracic. There is 2 types of thoracic claws: pediculo/transverse or pediculo/laminar. There is only 1 type of lumbar claw: lamino/laminar lumbar claw. IMPORTANT: In countries where the use of pedicle screws is restricted at thoracic levels (e.g. USA), vertebral claws are only recommended. 1. THORACIC FIXATION USING A PEDICULO/TRANSVERSE CLAW: Combination of a polyaxial pedicle hook for claw available in 2 sizes: 4 mm (MS ) or 6 mm (MS 421-1) and a transverse counterhook: MS 420-2S (with a short connecting rod) or MS 420-2L (with a long connecting rod). Preparation for insertion of the threaded connecting rod: partial resection of the base of the transverse process of the underlying vertebra using a rongeur. This step is important as it facilitates both placement of the threaded connecting rod and nut, as well as handling of instruments. Preparation for placement of the pedicle hook using the Pedicle hook starter (MS 504). Preparation for placement of the transverse hook using the laminar and transverse process hook starter (MS 505) at the superior part of the transverse process. NOTE: The resection of the inferior articular process of the above vertebra is also useful except if the joint has to be respected (claw of the upper extremity of the construct). 11

12 P O L Y A X I A L S P I N E S Y S T E M insertion of vertebral anchors Claw Fixation 2 Placement of the transverse counter hook using the hook holder (MS503) and the hexagonal positioner wrench for claw (MS512). Positioning of the pedicle hook using the Hook inserter set (MS502) option : 2 nd insertion technique Placement of the pedicle hook using the Hook inserter set (MS 502). 1 12

13 S U R G I C A L T E C H N I Q U E 2 3 Positioning of the transverse counterhook using the Hook holder (MS 503). Slightly tilt the pedicle hook adapted to the Hook inserter in order to facilitate the introduction. Orientation and placement of the transverse counterhook using the Hexagonal hook positionner wrench (MS 512). IMPORTANT: to facilitate the placement of the transverse counterhook, using a COBB can be helpful. Initial closing of the claw using the Compressor forceps for claw (MS 507). Tightening of the locking nut on the threaded connecting rod using the Flexible nutdriver for claw (MS 510). NOTE: The claw locking nut should be tight enough to allow the use of the Ratcheting wrench (MS 515). 13

14 P O L Y A X I A L S P I N E S Y S T E M insertion of vertebral anchors Claw Fixation 2 Final tightening with the Ratcheting wrench (MS 515). This Ratcheting wrench provides a powerful tightening, therefore, be careful not to overtighten the nut and stop as soon as resistance is felt. Tightening direction is marked on the instrument. NOTE: A double end wrench for claw nut (MS 513) is also available. 2. THORACIC FIXATION USING A PEDICULO/LAMINAR CLAW: Combination of a polyaxial pedicle hook for claw, available in 2 sizes: 4 mm (MS ) or 6 mm (MS 421-1) and a supra-laminar counterhook: MS 421-2S (with a short connecting rod) or MS 421-2L (with a long connecting rod). Preparation for insertion of the threaded connecting rod: partial resection of the transverse process basis of the underlying vertebra using a rongeur. This step is important as it facilitates both placement of the threaded connecting rod and locking nut, and handling of instruments (see figure p.11). Preparation of the pedicle hook placement using the Pedicle hook starter (MS 504) (see figure p.11). Preparation of the site for the supra-laminar counterhook using a Kerisson punch. The creation of a large window is recommended to ease the insertion of the counterhook by simple rotation, without tilting. NOTE: The resection of the inferior articular process of the above vertebra is also useful except if the joint has to be respected (claw of the upper extremity of the construct). Placement of the pedicle hook using the Hook inserter set (MS 502) (see figure p.12). 14

15 S U R G I C A L T E C H N I Q U E Positioning of the supra-laminar counterhook using the Hook holder (MS 503). Slightly tilt the pedicle hook adapted to the Hook inserter in order to facilitate the introduction. Orientation and placement of the supra-laminar counterhook using the Hexagonal positionner wrench (MS 512). IMPORTANT: The use of a COBB can ease the placement of the supra-laminar counterhook. Initial closing of the claw using the Compressor forceps for claw (MS 507) (see figure p.13). Tightening of the claw locking nut on the threaded connecting rod using the Flexible nutdriver for claw (MS 510) (see figure p.13). NOTE: The claw locking nut should be tight enough to allow the use of the Ratcheting wrench (MS 515). Final tightening with the Ratcheting wrench (MS 515), which provides powerful tightening. Therefore, be careful not to overtighten the nut and stop as soon as resistance is felt. Tightening direction is marked on the instrument (see figure p.14). NOTE: A double end wrench for claw nut (MS 513) is also available. 15

16 P O L Y A X I A L S P I N E S Y S T E M insertion of vertebral anchors Claw Fixation 2 3. LUMBAR FIXATION USING A LAMINO/LAMINAR CLAW: The lumbar claw consists of a combination between a polyaxial laminar hook for claw, available in 3 sizes: 7 mm (MS ), 9.3 mm (MS 430-1) or 11 mm (MS ) and a supra-laminar counterhook: MS S (with a short connecting rod) or MS L (with a long connecting rod). NOTE: Alternatively, the lumbar claw can be placed with the polyaxial laminar hook in the supra-laminar position and the counterhook in the infra-laminar position. Preparation for placement of the polyaxial infra-laminar hook using the Laminar and transverse process hook starter (MS 505). Preparation of the site for the supra-laminar counterhook using a Kerisson punch. The creation of a large window is recommended to ease the insertion of the counterhook by simple rotation, without tilting. 16

17 S U R G I C A L T E C H N I Q U E Placement of the polyaxial infra-laminar hook using the Hook inserter set (MS 502). Positioning of the supra-laminar counterhook using the hook holder (MS 503) (see figure p.15). Orientation and placement of the supralamina counterhook using the Hexagonal positionner wrench (MS 512) (see figure p.15). IMPORTANT: To ease the placement of the counterhook, using a COBB gouge can be helpful. Initial closing of the claw using the Compressor forceps for claw (MS 507) (see figure p.13). Tightening of the claw locking nut on the threaded connecting rod using the Flexible nutdriver for claw (MS 510) (see figure p.13). NOTE: The claw locking nut should be tight enough to allow the use of the Ratcheting wrench (MS 515). Final tightening with the Ratcheting wrench (MS 515), which provides powerful tightening. Therefore, be careful not to overtighten the nut and stop as soon as resistance is felt. Tightening direction is marked on the instrument (see figure p.15). NOTE: a double end wrench for claw nut (MS 513) is also available. 17

18 P O L Y A X I A L S P I N E S Y S T E M fixation using a sacral plate 3 1. INSERTION OF THE BICORTICAL S1 SCREW: Facetectomy: resection of the inferior articular process of L5 using a gouge chisel. Identification of the S1 pedicle entry point which is in the inferior part of the S1 articular surface. NOTE: in order to check the correct position, we recommand to use a lateral view from the image intensifier (C-arm). Creation of a starter hole following the good direction and according to the surgeon preference (use of a Straight spatula A , creation of the pathway through the anterior cortex for a bicortical fixation of the S1 screw. Test the pathway with the Pedicle probe (MS219). This pedicle feeler is used to check that the anterior cortex has been passed. Enlargement of the hole with a curette. Determination of the appropriate screw length using the depth gauge (A ). Placement of the sacral plate and insertion of the S1 screw with the 3.5 mm Hexagonal screwdriver (A ). 18

19 S U R G I C A L T E C H N I Q U E 2. INSERTION OF THE BICORTICAL INFERIOR SCREW INTO THE SACRUM ALA: Positioning of the plate. Its lower end is lying on the sacral ala, lateral to the first posterior sacral foramen. Determination of the entry point: the drill guide for sacral plate (MS 525) is inserted through the inferior hole of the sacral plate. The entry point is located lateral to the first sacral hole. It is also possible to adapt the handle for sacral plate drill guide (MS 524) to hold the guide. The straight threaded awl (A ) is inserted through the drill guide and gives the correct lateral and cephalad direction for the inferior screw. Creation of the inferior screw pathway through the anterior cortex for a bicortical fixation using the straight spatula (A ). Test the pathway with the pedicle probe (MS219). This pedicle feeler is used to check that the anterior cortex has been passed. Determination of the appropriate screw length using the depth gauge (A ). 19

20 P O L Y A X I A L S P I N E S Y S T E M fixation using a sacral plate 3 Insertion of the screw with the 3.5 mm Hexagonal screwdriver (A ). Sacral plates are coming with a polyaxial extension and in anatomical configuration (Left: MS 031, Right: MS030). 20

21 S U R G I C A L T E C H N I Q U E rod-plate construct 4 Using Flexible guiding tubes (MS 514) over the threaded extensions of each polyaxial implants will facilitate the positioning of the rod-plates at distance of the spine. IMPORTANT NOTE: When using a Screw to Screw Crosslink, the appropriate Crosslink length should be determined BEFORE loading the rod-plates over the flexible guiding tubes. With guiding tubes in place over two threaded extensions at the same level, load the Crosslink (marking facing upward) over the two guiding tubes. Should the Crosslink not slide all the way down on both sides, try an alternate length Crosslink. The final loading of the appropriate Screw to Screw Crosslink is described after (please refer to page 22). Rod-plates are offered in two versions (with 2 or 3 holes) for one or two-level instrumentation, each being available in two sizes, small and large (for proper sizing, please refer to above section, page 8). The rod-plates are positioned with the flexible guiding tubes in place over the threaded extensions of the anchorage points. Rod-plates are delivered pre-bent to match the lumbar or lumbo-sacral lordosis. The implantation of the rod-plates is restricted ONLY in this area. NOTE: Further bending of the rod-plate is not recommended, as this may cause distortion of the rod-plate holes. 21

22 P O L Y A X I A L S P I N E S Y S T E M rod-plate construct 4 In order to achieve a proper connection, make sure that the osteophytes have been removed (if any), with a rongeur. The circular hole in the rod-plate should always be positioned at the proximal end of the construct, away from the facet joints. Should the rod-plate holes not be aligned with the pedicle implants, a rod construct should be used. After the rod-plates have been loaded, the selected Screw to Screw Crosslink is connected over the flexible guiding tubes (marking facing upward). The locking nuts are loaded in the Nutdriver and and breaker instrument (A ) and partially tightened on top of the threaded extensions. NOTE: The locking nuts for pedicle screws are symetrical. A flat nut (MS001) has to be used with the sacral plates, all the polyaxial hooks or a screw to screw crosslink. This flat nut is delivered pre-charged with the hooks or sacral plates and separately for the Screw to Screw crosslink. LOCKING OF THE THREADED EXTENSION AND NUT TIGHTENING The nut tightening is achieved after a specific threaded post orientation and locking, using the Nutdriver and Positionner for Plate and Rod (MS 214). This instrument consists of two sliding parts: 1. The nutdriver is the outer part. 2. The alignment guide is the inner part. Its distal end is designed to fit the semicircular section at the superior extremity of the threaded extension in order to control the rotation. The 2 flats of the threaded extension basis have to be properly oriented to fit in the rod-plate. This blocks the rotation of the threaded extension during the nut tightening. The long T-handle of the alignment guide (inner part of MS 214) has to be perpendicular to the rod-plate axis. The drawing of the rod-plate (on this long T-handle) will face the surgeon (or his assistant, in front of him). This position of the long T-handle should be maintained during nut tightening. This step is critical to ensure proper locking of the rod-plate on the implants. To make sure that optimal tightening has been achieved, check that: the semicircular section at the end of the threaded extension is parallel to the rod-plate axis, AND the groove on the threaded extension is flush with the top surface of the nut. Should this not be the case, loosen the nut and change the orientation of the threaded extension so that the flats of its basis are properly captured within the rod-plate. 22

23 S U R G I C A L T E C H N I Q U E FINAL PROCEDURE Final tightening of each locking nut is realized with the nutdriver shaft for final tightening (A ). The position of this dynamometric nutdriver must go until the stop providing an optimal torque ranging between 12 and 13 Nm (8.85 and 9.59 lbf.ft). Thread the nutdriver and breaker instrument (A ) on top of the threaded extension and snap off along the longitudinal axis of the rodplate. At the end, after the threaded extension has been snapped off, check finally that its semicircular section is parallel to the rod-plate axis, and is flush with the top surface of the nut. 23

24 P O L Y A X I A L S P I N E S Y S T E M rod construct 5 Using Flexible guiding tubes (MS 514) over the threaded extensions of each polyaxial implants will facilitate positioning of the connecting clamps and rods at distance of the spine. IMPORTANT NOTE: When using a Screw to Screw Crosslink, the appropriate Crosslink length should be determined BEFORE loading the connecting clamps over the flexible guiding tubes. With guiding tubes in place over two threaded extensions at the same level, load the Crosslink (marking facing upward) over the two guiding tubes. Should the Crosslink not slide all the way down on both sides, try an alternate length Crosslink. The final loading of the appropriate Screw to Screw Crosslink is described after (please refer to page 30). BENDING OF THE RODS The rod is held with the Rod holder (A ) and contoured using the French rod bender (A ). The rod should be bent to the ideal sagittal curve, according to the instrumented levels and length of the construct. A longitudinal line can assist the rod contouring. A selection of the appropriate rod length and determination of the ideal shape can be facilitated by using the malleable rod (A or A ). NOTE : For short rods (from 40 to 110 mm) our PASSmed system provides pre-bent rods to facilitate the rod contouring by the surgeon. IMPORTANT: for traceability reasons we do not recommend the cutting of our rods. 24

25 S U R G I C A L T E C H N I Q U E A rod construct requires the use of connecting clamps. LOADING OF THE CONNECTING CLAMPS The upper and lower parts of the connecting clamps have distinct geometries: The top of the chosen clamp which is identified by laser marking (letter T or S ) will receive the locking nut. The lower part of the clamp fits the hemispherical part of the implant head (polyaxial Screw, Hook or Sacral plate). There are two types of connecting clamps: (a) Special connecting clamp (MS 012) which is marked S (for superior). This connecting clamp has been specially designed to slide easier along a bent rod due to a beveled edge. (b) Realignment connecting clamp (MS 121) which has a golden color and is thicker in its lower part than the standard connecting clamp. The top of the clamp is identified by the letter T and the word RAPPEL. This clamp is only used if the surgeon needs a realignment effect between the pedicular part of a pedicle screw and its posterior threaded extension. At the end of tightening, the hemispherical part of the screw head will be completely countersunk in the lower part of the clamp, and the polyaxial screw will be perpendicular to the rod (like a standard monoaxial screw). It can be useful when a vertebral realignement is necessary, ie.: spondylolisthesis or fracture. We do not recommend the use of a realignment connecting clamp in case of poor bone quality (i.e.: severe osteoporosis ). (b) (a) (b) NOTE: A Connecting clamp releaser (MS 227) can be used if necessary to open gently the connecting clamp and facilitates its sliding along the rod in case of severe bending. ADAPTATION OF THE RODS Connecting clamps are adapted on the first rod. Then, this assembly is dropped over the Flexible guiding tubes and brought down to the implants, usually with the rods placed medially to the implants. 25

26 P O L Y A X I A L S P I N E S Y S T E M rod construct 5 If necessary, use the Rod pusher (A ) to facilitate rod approximation. The threaded extensions are completely free during this step and there is no stress on the anchorage. In order to achieve a proper connection, make sure that the osteophytes have been removed (if any), with a rongeur. After the rod has been loaded with the appropriate connecting clamps, the selected Screw to Screw Crosslink is connected over the flexible guiding tubes (marking facing upward). The locking nuts are loaded in the Nutdriver and and breaker instrument (A ) and partially tightened on top of the threaded extensions. NOTE: The locking nuts for pedicle screws are symmetrical. A flat nut has to be used with the sacral plates, all the polyaxial hooks or a Screw to Screw crosslink. This flat nut is delivered pre-charged with the hooks or sacral plates and separatly (MS001) for the Screw to Screw crosslink. 26

27 S U R G I C A L T E C H N I Q U E When all the locking nuts are adapted to each threaded extensions, the rod is then positioned in the correct sagittal plane. A rod rotating wrench (A ) is available to assist in rotating the rod (when needed). Apply the wrenches to the flats, at the end of the rod. LOCKING OF THE THREADED EXTENSION AND NUT TIGHTENING The nut tightening is achieved after a specific threaded post orientation and locking, using the Nutdriver and Positionner for Plate and Rod (MS 214) which blocks rotation and locks direction of the threaded extension during nut tightening. This instrument consists of two sliding parts: 1. The nutdriver is the outer part. 2. The alignment guide is the inner part. Its distal end is designed to fit the semicircular section at the superior extremity of the threaded extension in order to control the rotation. The 2 flats of the threaded extension basis have to be properly oriented to fit into the rod. This blocks the rotation of the threaded extension during the nut tightening. The long T-handle of the alignment guide (inner part of MS 214) has to be parallel to the rod axis. The drawing of the rod (on this long T-handle) will face the surgeon (or his assistant, in front of him). This position of the long T-handle should be maintained during nut tightening. This step is critical to ensure proper locking of the rod-plate on the implants. To make sure that optimal tightening has been achieved, check that: the semicircular section at the end of the threaded extension is perpendicular to the rod axis, AND the groove on the threaded extension is flush with the top surface of the nut. Should this not be the case, loosen the nut and change the orientation of the threaded extension so that the flats of its basis are properly captured within the connecting clamp. 27

28 P O L Y A X I A L S P I N E S Y S T E M rod construct 5 DISTRACTION-COMPRESSION Before the final tightening and procedure, it may be necessary to use distraction or compression at the instrumented levels. When using a rod construct, distraction should be applied with the Spreader (A ) associated with the standard jaws for spreader A : Position the forks of the instrument on the rod, flush against the inner sides of the adjacent connecting clamps. Compression can be achieved with the Compressor A associated with the standard jaws for compressor A : As with the Spreader, position the forks of the instrument on the rod, flush against the outer sides of the adjacent connecting clamps. OPTION : A L shaped jaws (A ) can be also used to apply both distraction or compression directly on the connecting clamps. FINAL PROCEDURE Final tightening of each locking nut is realized with the nutdriver shaft for final tightening (A ). The position of this dynamometric nutdriver must go until the stop providing an optimal torque ranging between 12 and 13 Nm (8.85 and 9.59 lbf.ft). The Countertorque (A ) is used to stabilize the rod during the final tightening of the nut. 28

29 S U R G I C A L T E C H N I Q U E Thread the Nutdriver and breaker instrument (A ) on top of the threaded extension and snap off along the longitudinal axis of the rod. At the end, after the threaded extension has been snapped off, check finally that its semicircular section is perpendicular to the rod axis, and is flush with the top surface of the nut. NOTE: The extension of the assembly is possible through the use of 2 types of dominos (Open/Closed Domino MS025 or Closed Domino MS026) and their Screwdriver (A ). 29

30 P O L Y A X I A L S P I N E S Y S T E M rod to rod linkage 6 1. TRANSVERSE LINK: A Rod-to-Rod transverse link can be adapted to the construct at the end of the surgery. 3 sizes are available (MS 452, MS 453 and MS 454). Freedom of the threaded rod within the two hooks allows easy placement of the Transverse link whatever the respective positions of the rods. The Transverse link stability and rigidity are achieved with compression through tightening of the lateral lock nut. The initial threading of the lock nut is performed with the Double end wrench for claw nut (MS 513) until the lock nut is tight enough to allow the use of the Ratcheting wrench (MS 515) which tights and provides the compression. 2. Crosslink System: The Crosslink System is composed of two connectors pre-connected on one connecting plate. This implant is available in 3 sizes (MS , MS and MS ) covering the distances between rods from 22 mm to 62 mm. 1 Before positioning the connectors, please check that the rod passage is free. If not, release the passage by untightening the central axis using the MS64102 stylet until stop position (see figure 1). 2 Once the connector is on the rod, to prevent a rod escape during distraction and compression manoeuvres, it is necessary to tighten the central axis until stop using the MS64102 Stylet. The Crosslink can then slide freely along the rod without escape, and a gentle compression or distraction can be applied between the 2 rods (see figure 2). Final Locking is achieved by tightening the locking nut using the Screwdriver A pre-assembled with the handle A (see figure 3). 3 The handle A should not be used to perform the final tightening. 30

31 S U R G I C A L T E C H N I Q U E reduction of the deformity 7 Using Flexible guiding (MS 514) over the threaded extensions of each polyaxial implants will facilitate positioning of the connecting clamps and rods at distance of the spine. The connecting clamps are adapted on the first rod (generally the convex rod of the deformity). To turn the rods the surgeon will use 2 Rod grippers (MS511). The 2 rods can be rotated separately or simultaneously. IMPORTANT: When a rod is properly oriented, it must be locked on an implant (a claw or a screw) at the upper end of the construct. 31

32 P O L Y A X I A L S P I N E S Y S T E M reduction of the deformity 7 Progressive reduction of a deformity is achieved through an alternative tightening of all the nuts on both rods. With gentle tightening, the reduction forces are distributed over all the vertebrae toward the rods, as illustrated on the following pictures. NOTE: PASSmed instrumentation allows also the reduction of deformities using a rotation manoeuvre. This rotation manoeuvre can be associated at any time with a translation manœuvre. IN SITU BENDING In order to perform in situ bending, a Ø6 mm rod (length 500 mm) made of Pure Titanium T40 (B ) was specially integrated to the PASSmed System. To avoid any confusion with the standard rods, this rod is colored in blue. The in situ bending will be achieved by using the Right in situ Bender (A ) and the left in situ Bender (A ). 32

33 IMPLANTS REF. DESIGNATION* REF. DESIGNATION* MS 183C MS 177C MS 167C MS 168C MS 169C MS 170C MS 184C MS 178C MS 171C POLYAXIAL CYL. PEDICULAR SCREW D.4,5mm L.25mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.4,5mm L.28mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.4,5mm L.31mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.4,5mm L.34mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.4,5mm L.38mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.4,5mm L.42mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.5,5mm L.25mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.5,5mm L.28mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.5,5mm L.31mm with nut MS 348C MS 359C MS 349C MS 350C MS 351C MS 352C MS 353C MS 354C MS 358C MS 108 SACRAL SCREW D. 6.5mm L. 60mm SACRAL SCREW D. 7,2mm L.30mm SACRAL SCREW D. 7,2mm L. 34mm SACRAL SCREW D. 7,2mm L. 38mm SACRAL SCREW D. 7,2mm L. 42mm SACRAL SCREW D. 7,2mm L. 46mm SACRAL SCREW D. 7,2mm L. 50mm SACRAL SCREW D. 7,2mm L. 54mm SACRAL SCREW D. 7,2mm L. 58mm ROD-PLATE 1 LEVEL SMALL MS 172C POLYAXIAL CYL. PEDICULAR SCREW D.5,5mm L.34mm with nut MS 109 ROD-PLATE 1 LEVEL LARGE MS 173C POLYAXIAL CYL. PEDICULAR SCREW D.5,5mm L.38mm with nut MS 110 ROD-PLATE 2 LEVELS SMALL MS 174C POLYAXIAL CYL. PEDICULAR SCREW D.5,5mm L.42mm with nut MS 111 ROD-PLATE 2 LEVELS LARGE MS 175C POLYAXIAL CYL. PEDICULAR SCREW D.5,5mm L.46mm with nut MS 012 SPECIAL CONNECTING CLAMP for DEFORMITY MS 176C POLYAXIAL CYL. PEDICULAR SCREW D.6,5mm L.31mm with nut MS 121 SPECIAL REALIGNMENT CLAMP MS 162C POLYAXIAL CYL. PEDICULAR SCREW D.6,5mm L.34mm with nut MS 129 ROD D. 6mm L. 40mm MS 106C POLYAXIAL CYL. PEDICULAR SCREW D.6,5mm L.38mm with nut MS 127 ROD D. 6mm L. 50mm MS 160C MS 161C MS 179C MS 180C MS 654C MS 658C MS 164C MS 163C MS 165C MS 107C MS 166C POLYAXIAL CYL. PEDICULAR SCREW D.6,5mm L.42mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.6,5mm L.46mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.6,5mm L.48mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.6,5mm L.50mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.6,5mm L.54mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.6,5mm L.58mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.7,2mm L.34mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.7,2mm L.38mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.7,2mm L.42mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.7,2mm L.44mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.7,2mm L.46mm with nut MS 122 MS 130 MS 123 MS 132 MS 124 MS 125 MS 133 MS 131 MS 128 MS 134 MS 135 MS 126 ROD D. 6mm L. 60mm ROD D. 6mm L. 70mm ROD D. 6mm L. 80mm ROD D. 6mm L. 90mm ROD D. 6mm L. 100mm ROD D. 6mm L. 110mm ROD D. 6mm L. 120mm ROD D. 6mm L. 130mm ROD D. 6mm L. 150mm ROD D. 6mm L. 170mm ROD D. 6mm L. 190mm ROD D. 6mm L. 210mm MS 181C POLYAXIAL CYL. PEDICULAR SCREW D.7,2mm L.48mm with nut MS 137 ROD D. 6mm L. 230mm MS 182C POLYAXIAL CYL. PEDICULAR SCREW D.7,2mm L.50mm with nut MS 136 ROD D. 6mm L. 240mm MS 754C POLYAXIAL CYL. PEDICULAR SCREW D.7,2mm L.54mm with nut MS 138 ROD D. 6mm L. 250mm MS 758C POLYAXIAL CYL. PEDICULAR SCREW D.7,2mm L.58mm with nut MS 150 ROD D. 6mm L. 260mm MS 838C POLYAXIAL CYL. PEDICULAR SCREW D.8mm L.38mm with nut MS 151 ROD D. 6mm L. 280mm MS 842C POLYAXIAL CYL. PEDICULAR SCREW D.8mm L.42mm with nut MS 152 ROD D. 6mm L. 300mm MS 846C POLYAXIAL CYL. PEDICULAR SCREW D.8mm L.46mm with nut MS 153 ROD D. 6mm L. 320mm MS 850C POLYAXIAL CYL. PEDICULAR SCREW D.8mm L.50mm with nut MS 154 ROD D. 6mm L. 340mm MS 854C POLYAXIAL CYL. PEDICULAR SCREW D.8mm L.54mm with nut MS 155 ROD D. 6mm L. 360mm MS 304C MS 305C MS 306C MS 307C MS 302C MS 303C MS 300C MS 301C MS400 MS401 MS410 MS411 POLYAXIAL CYL. PEDICULAR OFFSET 3mm SCREW D.5,5mm L.38mm with nut POLYAXIAL CYL. PEDICULAR OFFSET 6mm SCREW D.5,5mm L.38mm with nut POLYAXIAL CYL. PEDICULAR OFFSET 3mm SCREW D.5,5mm L.42mm with nut POLYAXIAL CYL. PEDICULAR OFFSET 6mm SCREW D.5,5mm L.42mm with nut POLYAXIAL CYL. PEDICULAR OFFSET 3mm SCREW D.6,5mm L.38mm with nut POLYAXIAL CYL. PEDICULAR OFFSET 6mm SCREW D.6,5mm L.38mm with nut POLYAXIAL CYL. PEDICULAR OFFSET 3mm SCREW D.6,5mm L.42mm with nut POLYAXIAL CYL. PEDICULAR OFFSET 6mm SCREW D.6,5mm L.42mm with nut 4mm POLYAXIAL PEDICLE HOOK 6mm POLYAXIAL PEDICLE HOOK 6mm POLYAXIAL LUMBAR LAMINAR HOOK 8mm POLYAXIAL LUMBAR LAMINAR HOOK MS 156 MS 157 MS 191 MS 192 MS 147 MS 158 MS 159 MS 139 B B B B B ROD D. 6mm L. 380mm ROD D. 6mm L. 400mm ROD D. 6mm L. 420mm ROD D. 6mm L. 440mm ROD D. 6mm L. 450mm ROD D. 6mm L. 500mm ROD D. 6mm L. 550mm ROD D. 6mm L. 600mm PRE BENT ROD 6mm L. 40mm PRE BENT ROD 6mm L. 50mm PRE BENT ROD 6mm L. 60mm PRE BENT ROD 6mm L. 70mm PRE BENT ROD 6mm L. 80mm MS412 10mm POLYAXIAL LUMBAR LAMINAR HOOK B PRE BENT ROD 6mm L. 90mm MS mm POLYAXIAL PEDICLE HOOK for CLAW B PRE BENT ROD 6mm L. 100mm MS mm POLYAXIAL PEDICLE HOOK for CLAW B PRE BENT ROD 6mm L. 110mm MS mm POLYAXIAL LUMBAR LAMINAR HOOK for CLAW MS 001 NUT for CROSSLINK MS ,3mm POLYAXIAL LUMBAR LAMINAR HOOK for CLAW MS 148 CROSSLINK L = 30mm MS mm POLYAXIAL LUMBAR LAMINAR HOOK for CLAW MS 149 CROSSLINK L = 35mm MS421-2S 7mm LAMINAR THORACIC HOOK for SHORT CLAW MS 140 CROSSLINK L = 40mm MS420-2S 8mm LAMINAR LUMBAR or TRANSVERSE HOOK for SHORT CLAW MS 141 CROSSLINK L = 45mm MS430-2S MS421-2L MS420-2L MS430-2L MS 031 MS 030 9,3mm LAMINAR LUMBAR HOOK for SHORT CLAW 7mm LAMINAR THORACIC HOOK for LARGE CLAW 8mm LAMINAR LUMBAR or TRANSVERSE HOOK for LARGE CLAW 9,3mm LAMINAR LUMBAR HOOK for LARGE CLAW LEFT SACRAL PLATE RIGHT SACRAL PLATE MS 142 MS 143 MS 144 MS 145 MS 146 MS 452 CROSSLINK L = 50mm CROSSLINK L = 55mm CROSSLINK L = 60mm CROSSLINK L = 65mm CROSSLINK L = 70mm SMALL TRANSVERSE LINK MS 342C SACRAL SCREW D. 6.5mm L. 30mm MS 453 MEDIUM TRANSVERSE LINK MS 343C MS 344C MS 345C MS 346C MS 347C SACRAL SCREW D. 6.5mm L. 35mm SACRAL SCREW D. 6.5mm L. 40mm SACRAL SCREW D. 6.5mm L. 45mm SACRAL SCREW D. 6.5mm L. 50mm SACRAL SCREW D. 6.5mm L. 55mm MS 454 B MS025 MS026 MS LARGE TRANSVERSE LINK Ø6 x 500mm ROD for in situ bending Open/Closed Domino for Ø6mm rod Closed Domino for Ø6mm rod Crosslink System for Ø6mm rod, Distances 22 to 34mm MS Crosslink System for Ø6mm rod, Distances 34 to 48mm MS Crosslink System for Ø6mm rod, Distances 48 to 62mm B Locking nut * Not all items listed have been FDA approved and may not be available within the US market. Please check with Medicrea USA Customer Service for more information ( ).

34 Rod construct Pre-op Post-op Rod plate construct Pre-op Post-op Headquarters: MEDICREA 24 porte du Grand Lyon NEYRON - FRANCE Tél. +33 (0) Fax +33 (0) customerservice@medicrea.com Manufacturer: MEDICREA Technologies Z.I. Chef de Baie LA ROCHELLE - FRANCE Tel. +33 (0) Fax +33 (0) RCS La Rochelle SAS au capital de Euros Distributed by: FDA cleared Ref. C01D02004-V01 Dec 07 Médicrea. All rights reserved. Patented products. Illustrations by