POLYAXIAL SPINE SYSTEM SURGICAL TECHNIQUE
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- Roberta Higgins
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1 POLYAXIAL SPINE SYSTEM SURGICAL TECHNIQUE
2 P O L Y A X I A L S P I N E S Y S T E M 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 MS 219 Pedicle probe MS 218 Pedicle Square Awl reamer MS 210 Straight threaded awl MS 221 Squared awl MS 506 Bone probe MS 241 Straight spatula MS 242 Curved spatula MS 223 Rod compressor MS 222 Rod spreader MS 224 Dual position fast locking handle MS mm Hex hollow screw and nutdriver MS 206 Plate spreader MS 207 Plate compressor MS 214 Nutdriver and positionner for plate and rod MS 205 Pusher MS 209 Templates set for rod plates MS 215 Countertorque, MS 204 Obturator for plates MS 216 Rod rotating wrench (a pair) MS 212 Selfholding nutdriver and breaker MS 514 Flexible guiding tube MS 220 Rod holder MS 513 Double end wrench for claw nut MS 203 3,5 mm Hexagonal Screwdriver MS 508 Depth gauge MS 525 Drill guide for sacral plate MS 524 Handle for sacral plate drill guide MS 208 French rod bender MS 227 Connecting clamp releaser MS 509 Template for rod L.350mm MS 511 Rod gripper MS213 T20 Screwdriver MS64102 Stylet with 2.5 mm Hexagon for Crosslink System A mm Hex Hollow Screwdriver for Crosslink System A Right in situ bender A Left in situ bender MS Universal T-Handle MS 237 Tap for Dia. 4.5 mm pedicle screw MS 238 Tap for Dia. 5.5 mm pedicle screw MS 239 Tap for Dia. 6.5 mm pedicle screw MS 240 Tap for Dia. 7.2 mm pedicle screw
4 MS 503 Hook holder MS 512 Hex. positionner wrench for claw MS 507 Compressor forceps for claw MS 502 Hook inserter set MS 505 Laminar and transverse process hook starter MS 504 Pedicle hook starter MS 510 Flexible nutdriver for claw MS 515 Ratcheting wrench for claw nut
5 S U R G I C A L T E C H N I Q U E This Spine Internal Fixation device is the result of a collaboration between a group of spinal surgeons and the company MEDICREA since Thanks to a simple and solid construct made of Titanium (Ti-6Al-4V Eli), PASSmed facilitates spinal osteosynthesis in Thoraco-Lumbar or Lumbo- Sacral areas and the correction of various types of spinal deformities. SUMMARY 1. Lumbar Spine Thoracic Spine Thoracic fixation using a pediculo/transverse claw Thoracic fixation using a pediculo/laminar claw Lumbar fixation using a lamino/laminar claw Insertion of the S1 screw Insertion of the bicortical inferior screw into the sacrum ala Rod-plate construct Rod Construct Transverse link Crosslink system 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 The PASSmed polyaxial screws are available in different diameters and lengths. Each diameters are colour 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. 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). Ø (mm): 4,5 5,5 6,5 7, 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 (MS 221): 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 (MS 242) (or the Bone probe MS 506), with the concave surface of the instrument facing the spinal canal. NOTE: The Straight threaded awl (MS 210) can also be used to prepare the pedicule pathway. Test the pathway with the Pedicle probe (MS 219). 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 Enlargement of the hole with a curette and retesting with the Pedicle probe (MS 219). NOTE : In case of hard bone, it can be useful to use one of the taps (MS 238, MS 239 or MS 240 according to the screw diameter to be implanted), to prepare the pedicle screw insertion. Preparation of the screw seating: in some cases a Pedicle reamer (MS 218) 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 10 mm Hex hollow Screw and Nutdriver (MS 211). 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 Location of the pedicle entry point and creation of a pilot hole using the awl (MS 221): 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 (MS 242) (or the Bone probe MS 506), with the concave surface of the instrument facing the spinal canal (see figure p.7). NOTE: The Straight threaded awl (MS 210) can also be used to prepare the pedicule pathway. Test the pathway with the pedicle probe (MS 219). 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 (MS 219) (see figure p.8). NOTE: In case of hard bone, and WITH PRECAUTION, the tap MS 237 can be used to prepare the insertion of the Dia. 4.5mm screw in the pedicle. (see figure p. 8). Insertion of the screw with the 10mm Hex hollow Screw and Nutdriver (MS 211) (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 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 only are 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, and handling of instruments. Preparation for placement of the pedicle hook using the Pedicle hook starter (MS 504). 11
12 P O L Y A X I A L S P I N E S Y S T E M 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). Placement of the pedicle hook using the Hook inserter set (MS 502). 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. 12
13 S U R G I C A L T E C H N I Q U E 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 lock nut on the threaded connecting rod using the Flexible nutdriver for claw (MS 510). NOTE: The claw lock 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 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 lock 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 lock nut on the threaded connecting rod using the Flexible nutdriver for claw (MS 510) (see figure p.13). NOTE: The claw lock 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 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 lock nut on the threaded connecting rod using the Flexible nutdriver for claw (MS 510) (see figure p.13). NOTE: The claw lock 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 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 (MS 241), creation of the pathway through the anterior cortex for a bicortical fixation of the S1 screw. Test the pathway with the Pedicle probe (MS 219). 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 (MS 508). Placement of the sacral plate and insertion of the S1 screw with the 3.5 mm Hexagonal screwdriver (MS 203). 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 (MS 210) 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 (MS 241). Test the pathway with the Pedicle probe (MS 219). This pedicle feeler is used to check that the anterior cortex has been passed. Determination of the appropriate screw length using the Depth gauge (MS 508). 19
20 P O L Y A X I A L S P I N E S Y S T E M Insertion of the screw with the 3.5 mm Hexagonal screwdriver (MS 203). Sacral plates are coming with a polyaxial extension and in anatomical configuration (Left: MS 031, Right: MS 030). 20
21 S U R G I C A L T E C H N I Q U E 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 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 (MS 212) and partially tightened on top of the threaded extensions. NOTE: The locking nuts for pedicle screws are sym-metrical. 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 (MS 001) 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 nuts is realized with the 10mm Hex hollow Screw and Nutdriver (MS 211). The Countertorque (MS 215) is used to stabilize the rod-plate during final tightening of the nut. Thread the nutdriver and breaker instrument (MS 212) on top of the threaded extension and snap off along the longitudinal axis of the rod-plate. 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 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 (MS 220) and contoured using the French rod bender (MS 208). 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 Template for rod (MS 509). IMPORTANT: for traceability reasons we do not recommand 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 three types of connecting clamps: (a) Standard connecting clamp (MS 120) which is marked T on the top. (b) Special connecting clamp for deformity (MS 012) which is marked S (for superior). This connecting clamp has been specially designed to slide more easily along a bent rod thanks to a bevelled edge. (c) 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 recommand the use of realignment connecting clamp in case of poor bone quality (i.e.: severe osteoporosis...). (b) (a) (b) (c) 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 If necessary, use the Pusher (MS 205) 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 (MS 212) 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 (MS 001) 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. 2 Rod rotating wrenches (MS 216) are available, one straight, one angled 45, to assist in rotating the rod (when needed). Apply the wrenches to the flats, at each 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 in 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 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 Rod spreader (MS222): 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 Rod compressor (MS 223): As with the rod spreader, position the forks of the instrument on the rod, flush against the outer sides of the adjacent connecting clamps. NOTE: For a rod-plate construct, the surgeon can use a Plate spreader or a Plate compressor (MS 206 and MS 207 respectively).these 2 instruments can also be used in a rod construct. FINAL PROCEDURE Final tightening of each locking nuts is realized with the 10mm Hex hollow Screw and Nutdriver (MS211). The Countertorque (MS 215) is used to stabilize the rod during 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 (MS 212) 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 (MS213). 29
30 P O L Y A X I A L S P I N E S Y S T E M Two types of Rod to Rod links are available in the PASSmed System : The Transverse Link and the Crosslink System. 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). Once the connector is on the rod, and 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). 2 Final Locking is achieved by tightening the locking nut using the Screwdriver A preassembled with the Universal handle MS224 positioned imperatively in the axis of the Screwdriver (see figure 3). 3 The handle should not be used in the T position to perform the final tightening. 30
31 S U R G I C A L T E C H N I Q U E Using Flexible guiding (MS 514) over the threated 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 (MS 511). 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 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. MS 183C MS 177C MS 167C MS 168C MS 169C MS 170C MS 184C MS 178C MS 171C MS 172C MS 173C MS 174C MS 175C MS 625C MS 628C MS 176C MS 162C MS 106C MS 160C MS 161C MS 179C MS 180C MS 654C MS 658C MS 728C MS 359C MS 731C MS 164C MS 163C MS 165C MS 107C MS 166C MS 181C MS 182C MS 754C MS 758C MS 834C MS 838C MS 842C MS 844C MS 846C MS 848C MS 850C MS 854C MS 858C MS 304C MS 305C MS 306C MS 307C MS 302C MS 303C MS 300C MS 301C MS400 MS401 MS410 MS411 MS412 MS421-0 MS421-1 MS430-0 MS430-1 MS430-3 MS421-2S MS420-2S MS430-2S MS421-2L MS420-2L MS430-2L DESIGNATION 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 POLYAXIAL CYL. PEDICULAR SCREW D.5,5mm L.34mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.5,5mm L.38mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.5,5mm L.42mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.5,5mm L.46mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.6,5mm L.25mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.6,5mm L.28mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.6,5mm L.31mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.6,5mm L.34mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.6,5mm L.38mm with nut 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.28mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.7,2mm L.30mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.7,2mm L.31mm 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 POLYAXIAL CYL. PEDICULAR SCREW D.7,2mm L.48mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.7,2mm L.50mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.7,2mm L.54mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.7,2mm L.58mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.8mm L.34mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.8mm L.38mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.8mm L.42mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.8mm L.44mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.8mm L.46mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.8mm L.48mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.8mm L.50mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.8mm L.54mm with nut POLYAXIAL CYL. PEDICULAR SCREW D.8mm L.58mm with nut 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 10mm POLYAXIAL LUMBAR LAMINAR HOOK 4mm POLYAXIAL PEDICLE HOOK for CLAW 6mm POLYAXIAL PEDICLE HOOK for CLAW 7mm POLYAXIAL LUMBAR LAMINAR HOOK for CLAW 9,3mm POLYAXIAL LUMBAR LAMINAR HOOK for CLAW 11mm POLYAXIAL LUMBAR LAMINAR HOOK for CLAW 7mm LAMINAR THORACIC HOOK for SHORT CLAW 8mm LAMINAR LUMBAR or TRANSVERSE HOOK for SHORT CLAW 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 REF. MS 031 MS 030 MS 342C MS 343C MS 344C MS 345C MS 346C MS 347C MS 348C MS 349C MS 350C MS 351C MS 352C MS 353C MS 354C MS 358C MS 108 MS 109 MS 110 MS 111 MS 120 MS 012 MS 121 MS 129 MS 127 MS 122 MS 130 MS 123 MS 132 MS 124 MS 125 MS 133 MS 131 MS 128 MS 134 MS 135 MS 126 MS 137 MS 136 MS 138 MS 150 MS 151 MS 152 MS 153 MS 154 MS 155 MS 156 MS 157 MS 191 MS 192 MS 147 MS 158 MS 159 MS 139 MS 001 MS 148 MS 149 MS 140 MS 141 MS 142 MS 143 MS 144 MS 145 MS 146 MS 452 MS 453 MS 454 B MS025 MS026 DESIGNATION LEFT SACRAL PLATE RIGHT SACRAL PLATE SACRAL SCREW D. 6.5mm L. 30mm 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 SACRAL SCREW D. 6.5mm L. 60mm 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 ROD-PLATE 1 LEVEL LARGE ROD-PLATE 2 LEVELS SMALL ROD-PLATE 2 LEVELS LARGE STANDARD CONNECTING CLAMP SPECIAL CONNECTING CLAMP for DEFORMITY SPECIAL REALIGNMENT CLAMP ROD D. 6mm L. 40mm ROD D. 6mm L. 50mm 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 ROD D. 6mm L. 230mm ROD D. 6mm L. 240mm ROD D. 6mm L. 250mm ROD D. 6mm L. 260mm ROD D. 6mm L. 280mm ROD D. 6mm L. 300mm ROD D. 6mm L. 320mm ROD D. 6mm L. 340mm ROD D. 6mm L. 360mm 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 NUT for CROSSLINK CROSSLINK L = 30mm CROSSLINK L = 35mm CROSSLINK L = 40mm CROSSLINK L = 45mm CROSSLINK L = 50mm CROSSLINK L = 55mm CROSSLINK L = 60mm CROSSLINK L = 65mm CROSSLINK L = 70mm SMALL TRANSVERSE LINK MEDIUM TRANSVERSE LINK LARGE TRANSVERSE LINK Ø6 x 500mm ROD for in situ bending Open/Closed Domino for Ø6mm rod Closed Domino for Ø6mm rod MS 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
34 Headquarters: MEDICREA International 24 porte du Grand Lyon NEYRON - FRANCE Tél. +33 (0) Fax +33 (0) Manufacturer: MEDICREA Technologies Z.I. Chef de Baie LA ROCHELLE - FRANCE Tél. +33 (0) Fax +33 (0) Distributed by: Ref. : C01D V Médicréa. All rights reserved. Patented products. Illustrations by FDA cleared RCS La Rochelle SAS au capital de Euros customerservice@medicrea.com
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