Gibralt. Occipito-Cervico Thoracc System. Operative Technique

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Elijah Montgomery
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1 Gibralt Occipito-Cervico Thoracc System Operative Technique

TABLE OF CONTENTS GIBRALT...1 OPERATIVE TECHNIQUE OVERVIEW...2 HOOK PLACEMENT...2 SCREW PLACEMENT...2 DETAILED OPERATIVE TECHNIQUE...4 PLACEMENT OF LAMINAR HOOKS...4 PLACEMENT OF POLYAXIAL SCREWS.

..9 Rod-to-Rod Connectors...9 IMPLANT LISTING...10 INSTRUMENT LISTING...12 INDICATIONS FOR USE...17 GIBRALT OCCIPITAL PLATE...18 OPERATIVE TECHNIQUE OVERVIEW...19 DETAILED OPERATIVE TECHNIQUE.

2 TABLE OF CONTENTS GIBRALT...1 OPERATIVE TECHNIQUE OVERVIEW...2 HOOK PLACEMENT...2 SCREW PLACEMENT...2 DETAILED OPERATIVE TECHNIQUE...4 PLACEMENT OF LAMINAR HOOKS...4 PLACEMENT OF POLYAXIAL SCREWS...5 SCREW INSERTION...6 ROD PLACEMENT...6 SET SCREW INSERTION...7 COMPRESSION/DISTRACTION...8 FINAL TIGHTENING...8 ADDITIONAL OPTIONS...8 Head to Head Cross Connector Placement...8 Transitional Rods...9 Rod-to-Rod Connectors...9 IMPLANT LISTING...10 INSTRUMENT LISTING...12 INDICATIONS FOR USE...17 GIBRALT OCCIPITAL PLATE...18 OPERATIVE TECHNIQUE OVERVIEW...19 DETAILED OPERATIVE TECHNIQUE...20 SELECTION AND PLACEMENT OF THE OCCIPITAL PLATE...20 CONTOUR THE PLATE...20 DRILL...20 TAP...21 CENTER LINE SCREW INSERTION...21 CUT AND CONTOUR THE ROD...21 ROD INSERTION...22 SET SCREW INSERTION...22 INTIAL TIGHTENING OF THE ARTICULATING ROD...23 FINAL TIGHTENING...23 REMOVAL...23 IMPLANT LISTING...24 INSTRUMENT LISTING...24 INDICATIONS FOR USE...25

3 GIBRALT The Gibralt Spinal System is a comprehensive solution for posterior stabilization and fusion of the cervical and thoracic spine. Offering exceptional versatility and ease-of-use, the Gibralt Spinal System features top-loading polyaxial screws, hooks, offset connectors and rod-to-rod connectors which can be constructed into a multitude of configurations based on individual patient anatomy. 1

4 OPERATIVE TECHNIQUE OVERVIEW Hook Placement 1 Place Hooks 2 Insert Set Screws Screw Placement 3 Determine Entry Point 4 Cannulate the Pedicle 5 Test Pedicular Wall 6 Drill 7 Tap to Desired Depth 8 Insert Screw 2

5 9 Cut and Contour the Rod 10 Place Rod into Tulip Heads 11 Insert Set Screw 12 Tighten Set Screws 13 Compression/Distraction 14 Final Tightening 15 Additional Options Cross Connectors and Rod-to-Rod Connectors 3

DETAILED OPERATIVE TECHNIQUE PLACEMENT OF LAMINAR HOOKS Hooks are available for use in the cervical spine. Select the appropriate Hook size and configuration for the anatomy.

Clamp the desired Hook with the Hook Holder making sure that the prongs of the instrument interface with the indentations on the outside head of the Hook (Figure 1).

6 DETAILED OPERATIVE TECHNIQUE PLACEMENT OF LAMINAR HOOKS Hooks are available for use in the cervical spine. Select the appropriate Hook size and configuration for the anatomy. There are five different types of Hooks available Straight, Left and Right Offset and Left and Right Angle Hooks. Clamp the desired Hook with the Hook Holder making sure that the prongs of the instrument interface with the indentations on the outside head of the Hook (Figure 1). Place Hooks as needed under the superior or inferior lamina (Figure 2). Figure 1 Clamp Hook The Hooks may be oriented either in a cranial or caudal position. Once the Hooks have been inserted, utilize the Set Screw Starter to insert the appropriate inner Set Screw and provisionally tighten in a clockwise motion (Figure 3). Figure 2 Place Hooks Figure 3 Tighten Set Screw 4

Figure 5 Cannulate the Pedicle Figure 4 Determine Entry Point PLACEMENT OF POLYAXIAL SCREWS Determine the ideal entry point for the Polyaxial Screw and penetrate the cortical bone to initiate an

7 Figure 5 Cannulate the Pedicle Figure 4 Determine Entry Point PLACEMENT OF POLYAXIAL SCREWS Determine the ideal entry point for the Polyaxial Screw and penetrate the cortical bone to initiate an entry point using the Awl (Figure 4). The Probe can then be used to cannulate the pedicle (Figure 5). After the pedicle has been cannulated, it may be tested to ensure the integrity of the pedicular wall by using the Sounding Probe (Figure 6). Determine the desired diameter and depth of the drill penetration. There are two drill options available, Fixed and Adjustable. Fixed drills are available in either a 12mm or 14mm depth. Adjustable Drill and Drill Guide Stop offer a drilling depth range from 14mm to 28mm in 2mm increments. The depth is determined by the position of the drill guide stop on the adjustable drill. Figure 6 Test Pedicular Wall Attach the Drill Bit to the desired handle. Align the Drill Guide with the appropriate screw trajectory. Insert the Drill Bit through the Drill Guide and proceed with drilling to the desired depth (Figure 7). Confirm depth and containment within the pilot hole with the Depth Gauge or probe. Figure 7 Drill Tap the pilot hole using the 3.5 or 4.0mm Tap while maintaining the appropriate trajectory (Figure 8). Note: The Taps are undersized by approximately 0.15mm. Continue to drill and tap the remaining pilot holes in the same manner. 5

SCREW INSERTION Connect the Polyaxial Screwdriver to the desired Handle. After selecting the appropriate screw size, insert the hexalobe tip of the Screwdriver into the screw.

To disengage the screw from the driver, turn the knob counterclockwise to and pull straight out of the internal hexalobe on the screw.

Rotate the outer knob of the screwdriver clockwise until the screwdriver is secured to the screw. Once the screw is engaged, back out the screw by turning the handle counterclockwise.

8 SCREW INSERTION Connect the Polyaxial Screwdriver to the desired Handle. After selecting the appropriate screw size, insert the hexalobe tip of the Screwdriver into the screw. Rotate the outer knob of the Screwdriver clockwise until the head of the screw is secured on the Driver (Figure 9). Insert the screw into the prepared pilot hole to the desired depth (Figure 10). To disengage the screw from the driver, turn the knob counterclockwise to and pull straight out of the internal hexalobe on the screw. Figure 8 Tap to Desired Depth The Removal Screwdriver was designed to back out the polyaxial screws if needed. To back out the screw, insert the hexalobe tip of the screwdriver in to the screw. Rotate the outer knob of the screwdriver clockwise until the screwdriver is secured to the screw. Once the screw is engaged, back out the screw by turning the handle counterclockwise. Continue to insert all remaining Polyaxial Screws in the same manner. ROD PLACEMENT The rods are provided in pre-contoured, precut lengths, however a Rod Cutter is provided if other sizes are needed. The final length of the rod should extend 2mm beyond the margin of the screw housing so the screw locking mechanism engages correctly (Figure 11). To contour the rods, secure the rod with the Rod Bender and contour to achieve the desired curvature (Figure 12). Handheld Rod Benders are also available and can be used to provide additional leverage when contouring the rod. Utilize the removal screwdriver to adjust the A-P height of the screws as needed. Adjust the alignment of the Polyaxial Screws using the Head Turner so that the rod openings are in alignment. Once adjusted, they will easily stay in the correct alignment due to the unique EZ Set Tulip Design. Figure 10 Insert Screw Figure 11 Cut the Rod Figure 9 Secure Screw Head on Driver Figure 12 Use Rod Bender to Contour Rods 6

9 Figure 13 Place Rod into Tulip Heads Figure 14 Rod Persuader Place the contoured rod into Polyaxial Screw (Figure 13). If necessary, there are two options for reducing the rod into the Hook or screw heads. 1) The Rod Persuader can be placed over the head of the hook or screw and the handles compressed to reduce the rod (Figure 14). Figure 15 Inline Rod Persuader 2) There are also multiple Inline Rod Persuaders which fit over the individual screw heads. The Inline Rod Persuader Knob is inserted over the top of the Inline Rod Persuader and rotated clockwise to reduce the rod (Figure 15). The Rod Persuader Knob can then be removed and placed over the next Inline Rod Reducer to reduce the rod into the next screw head sequentially. SET SCREW INSERTION Determine the appropriate inner set screw for each Polyaxial Screw or Hook, depending on whether a cross connector will be used at the indicated level. Utilizing the threaded Set Screw Starter, insert the appropriate inner set screw into the Hooks and Polyaxial Screws and provisionally tighten in a clockwise motion (Figure 16). Figure 16 Insert Set Screw 7

COMPRESSION/DISTRACTION After the construct has been properly assembled, segmental compression and/or distraction can be accomplished using the Compressor or Distractor while tightening the Set

FINAL TIGHTENING To perform final tightening of the construct, insert the Set Screw Driver attached to the Torque Limiting Driver through the Counter Torque and turn the Torque Driver clockwise until

10 COMPRESSION/DISTRACTION After the construct has been properly assembled, segmental compression and/or distraction can be accomplished using the Compressor or Distractor while tightening the Set Screws sequentially (Figure 17). FINAL TIGHTENING To perform final tightening of the construct, insert the Set Screw Driver attached to the Torque Limiting Driver through the Counter Torque and turn the Torque Driver clockwise until the Torque Driver audibly clicks (Figure 18). Figure 17 Compressor Distractor Repeat in the same manner on all remaining components to secure the construct. ADDITIONAL OPTIONS Rod to Rod Cross Connector Placement Choose the appropriate size Rod to Rod Cross Connector and contour as needed, using the Cross Connector Benders provided. Capture the Cross Connector Nut with the Cross Connector Nut Starter to hold the cross connector and place onto the rod (Figure 19). Insert the Set Screwdriver attached to the Torque Limiting Driver though the Torque Limiting Nut Driver over the rod to rod cross connector nut into the set screw. Rotate the Torque Limiting Nut Driver counter clockwise until the Torque handle breaks over (Figure 20). Repeat the procedure on the opposite side to final tighten the construct. Figure 18 Final Tightening Figure 19 Place Cross Connector Head to Head Cross Connector Placement Choose the appropriate size Cross Connector and contour as needed, using the Cross Connector Benders provided (Figure 21). Note: It is critical that the Cross Connector be contoured in most situations so that both rings of the cross connector are flush with the base of the tulip. If not contoured correctly, the application of torque to the Cross Connector Nut may cause issues with the inner set screw. Place the Hook Holder around the outside of the Polyaxial Screw where the Cross Connector will be inserted. Capture the retaining nut with the Cross Connector Nut Starter and turn clockwise to thread onto the extended Set Screw (Figure 22). Figure 20 Final Tightening of Cross Connector 8

Attach the Torque Limiting Driver to the Nut Driver and rotate clockwise until it audibly clicks to secure the Cross Connecting Retaining Nut (Figure 23).

The Gibralt System offers two different types of transitional rods, which can be linked to thoracic components.

11 Attach the Torque Limiting Driver to the Nut Driver and rotate clockwise until it audibly clicks to secure the Cross Connecting Retaining Nut (Figure 23). Transitional Rods Transitional Rods and Rod Connectors are available to link to other ChoiceSpine Spinal Systems. The Gibralt System offers two different types of transitional rods, which can be linked to thoracic components. Figure 21 Use Cross Connector Benders to Bend Cross Connector Rod-to-Rod Connectors The Gibralt offers three different sizes of Rod-to-Rod Connectors for use with other ChoiceSpine Spinal Systems. 1) Axial Rod-to-Rod Connectors are available to connect 3.5mm to 5.5.mm and 3.5mm to 6mm rod sizes. 2) Wedding Band Connectors are available to connect 3.5mm to 5.5.mm and 3.5mm to 6mm rod sizes. 3) Inline Rod-to-Rod Connectors are available for 3.5mm to 3.5mm rods. To utilize a Rod-to-Rod connector, select the appropriate type and size and insert the end of the 3.5mm rod into the 3.5mm opening of the connector. Use the Set Screw Starter to engage the appropriate set screw by turning clockwise in the locking hole to secure the rod provisionally. Figure 22 Thread onto Set Screw Note: The open side of the wedding band connector utilizes the Rod to Rod Connector set screw. All other Rod to Rod Connectors utilize the Standard Set Screw. Next, insert the other rod (either 3.5mm, 5.5.mm or 6.0mm depending on the component used) into the remaining opening on the connector. Use the Set Screw Starter to engage the appropriate Set Screw by turning clockwise in the locking hole to secure the rod provisionally (Figure 24). Use the Set Screw Driver connected to the Torque Driver to tighten all Set Screws until the Torque Driver audibly clicks. Figure 23 Secure Cross Connector Figure 24 Wedding Band Rod-to-Rod Connector 9

IMPLANT LISTING Catalog Number 05-000-20-3510 05-000-20-3512 05-000-20-3514 05-000-20-3516 05-000-20-3518 05-000-20-3520 05-000-20-3522 05-000-20-3524 05-000-20-3526 05-000-20-3528 05-000-20-3530

05-000-20-4030 05-000-20-4032 05-000-20-4034 05-000-20-4036 05-000-20-4520 05-000-20-4525 05-000-20-4530 05-000-20-4535 05-000-20-4540 05-000-20-4545 05-000-20-4550 05-000-26-3520 05-000-26-3522

05-000-26-4030 05-000-26-4032 05-000-26-4034 05-000-26-4036 05-000-26-4038 Part Description Polyaxial Screw 3.5mm x 10mm Polyaxial Screw 3.5mm x 12mm Polyaxial Screw 3.5mm x 14mm Polyaxial Screw 3.

12 IMPLANT LISTING Catalog Number Part Description Polyaxial Screw 3.5mm x 10mm Polyaxial Screw 3.5mm x 12mm Polyaxial Screw 3.5mm x 14mm Polyaxial Screw 3.5mm x 16mm Polyaxial Screw 3.5mm x 18mm Polyaxial Screw 3.5mm x 20mm Polyaxial Screw 3.5mm x 22mm Polyaxial Screw 3.5mm x 24mm Polyaxial Screw 3.5mm x 26mm Polyaxial Screw 3.5mm x 28mm Polyaxial Screw 3.5mm x 30mm (Optional) Polyaxial Screw 3.5mm x 32mm (Optional) Polyaxial Screw 3.5mm x 34mm (Optional) Polyaxial Screw 3.5mm x 36mm (Optional) Polyaxial Screw 4.0mm x 10mm Polyaxial Screw 4.0mm x 12mm Polyaxial Screw 4.0mm x 14mm Polyaxial Screw 4.0mm x 16mm Polyaxial Screw 4.0mm x 18mm Polyaxial Screw 4.0mm x 20mm Polyaxial Screw 4.0mm x 22mm Polyaxial Screw 4.0mm x 24mm Polyaxial Screw 4.0mm x 26mm Polyaxial Screw 4.0mm x 28mm Polyaxial Screw 4.0mm x 30mm (Optional) Polyaxial Screw 4.0mm x 32mm (Optional) Polyaxial Screw 4.0mm x 34mm (Optional) Polyaxial Screw 4.0mm x 36mm (Optional) Polyaxial Screw 4.5mm x 20mm Polyaxial Screw 4.5mm x 25mm Polyaxial Screw 4.5mm x 30mm Polyaxial Screw 4.5mm x 35mm Polyaxial Screw 4.5mm x 40mm Polyaxial Screw 4.5mm x 45mm Polyaxial Screw 4.5mm x 50mm Polyaxial Smooth Shank Screw 3.5mm x 20mm Polyaxial Smooth Shank Screw 3.5mm x 22mm Polyaxial Smooth Shank Screw 3.5mm x 24mm Polyaxial Smooth Shank Screw 3.5mm x 26mm Polyaxial Smooth Shank Screw 3.5mm x 28mm Polyaxial Smooth Shank Screw 3.5mm x 30mm Polyaxial Smooth Shank Screw 3.5mm x 32mm Polyaxial Smooth Shank Screw 3.5mm x 34mm (Optional) Polyaxial Smooth Shank Screw 3.5mm x 36mm (Optional) Polyaxial Smooth Shank Screw 3.5mm x 38mm (Optional) Polyaxial Smooth Shank Screw 4.0mm x 20mm Polyaxial Smooth Shank Screw 4.0mm x 22mm Polyaxial Smooth Shank Screw 4.0mm x 24mm Polyaxial Smooth Shank Screw 4.0mm x 26mm Polyaxial Smooth Shank Screw 4.0mm x 28mm Polyaxial Smooth Shank Screw 4.0mm x 30mm Polyaxial Smooth Shank Screw 4.0mm x 32mm Polyaxial Smooth Shank Screw 4.0mm x 34mm (Optional) Polyaxial Smooth Shank Screw 4.0mm x 36mm (Optional) Polyaxial Smooth Shank Screw 4.0mm x 38mm (Optional)

13 Catalog Number Part Description Gibralt Curved Rod 30mm Gibralt Curved Rod 40mm Gibralt Curved Rod 50mm Gibralt Curved Rod 60mm Gibralt Curved Rod 70mm Gibralt Curved Rod 80mm Gibralt Curved Rod 90mm Set Screw Cross Connector Set Screw Cross Connector Retaining Nut Rod 3.5mm x 120mm Rod 3.5mm x 240mm Transitional Rod, 3.5mm to 5.5mm x 420mm Transitional Rod, 3.5mm to 6.0mm x 420mm Transitional Rod, 3.5mm to 5.5mm x 600mm Transitional Rod, 3.5mm to 6.0mm x 600mm Cross Connector, 22mm to 28mm Cross Connector, 28mm to 34mm Cross Connector, 34mm to 40mm Cross Connector, 40mm to 46mm Cross Connector, 46mm to 52mm Rod to Rod Cross Connector, 22mm to 30mm Rod to Rod Cross Connector, 26mm to 36mm Rod to Rod Cross Connector, 32mm to 42mm Rod to Rod Cross Connector, 38mm to 48mm Rod to Rod Cross Connector, 44mm to 52mm Set Screw for Rod to Rod Connectors Rod-to-Rod Connector, Inline, 3.5mm to 3.5mm Rod-to-Rod Connector, Combination, 3.5mm to 5.5mm Rod-to-Rod Connector, Combination, 3.5mm to 6.0mm Rod-to-Rod Connector, Wedding Band, 3.5mm to 5.5mm Rod-to-Rod Connector, Wedding Band, 3.5mm to 6.0mm Straight Hook 11

14 IMPLANT LISTING Catalog Number Part Description Left Angle Hook Right Angle Hook Offset Right Hook Offset Left Hook Offset Connector 12mm Lg. Offset Connector 15mm Lg. INSTRUMENT LISTING Catalog Number Part Description Awl Probe Sounding Probe mm Tap 4.0mm Tap Depth Gauge 12

15 Catalog Number Part Description mm Adjustable Drill mm x 12mm fixed drill bit 2.4mm x 14mm fixed drill bit Optional Drill Bits mm x 10mm Fixed Drill Bit 2.0mm x 12mm Fixed Drill Bit 2.0mm x 14mm Fixed Drill Bit 2.0mm x 16mm Fixed Drill Bit 2.4mm x 10mm Fixed Drill Bit 2.4mm x 12mm Fixed Drill Bit 2.4mm x 14mm Fixed Drill Bit 2.4mm x 16mm Fixed Drill Bit 2.7mm x 10mm Fixed Drill Bit 2.7mm x 12mm Fixed Drill Bit 2.7mm x 14mm Fixed Drill Bit 2.7mm x 16mm Fixed Drill Bit 3.0mm x 10mm Fixed Drill Bit 3.0mm x 12mm Fixed Drill Bit 3.0mm x 14mm Fixed Drill Bit 3.0mm x 16mm Fixed Drill Bit Adjustable Drill Stop Drill Guide AO Handle Removal Screwdriver Polyaxial Screwdriver Fixed Handle Polyaxial Screwdriver Gibralt Screwdriver Sleeve Set Screw Starter A/O Connection Double End Set Screw Starter (Optional) Set Screwdriver 13

05-009-51-0000 Counter Torque Cross Connectors

05-009-55-0000 Cross Connector Nut Driver

Handle 05-009-22-0000 Rod Bender 05-009-23-0001

16 INSTRUMENT LISTING Catalog Number Part Description Counter Torque Counter Torque Cross Connectors Cross Connector Nut Starter Cross Connector Nut Driver Gibralt Cross Connector Torque Handle Rod Bender In-Situ Rod Bender In-Situ Rod Bender Rod Cutter 14

Hook Holder 05-009-41-0000 Cross Connector

05-009-29-0000 Distractor 05-009-33-0000

17 Catalog Number Part Description Rod Holder Hook Holder Cross Connector Bender Compressor Distractor Rod Persuader Torque, Short T-Handle Axial Ratchet Handle, Square Drive Ratchet T-Handle, Square Drive 15

INSTRUMENT LISTING Catalog Number Part Description 05-009-35-0000 Contour Rod

Breaker 05-009-60-0000 Polyaxial Screw Countersink 05-009-65-0000 Inline Rod

18 INSTRUMENT LISTING Catalog Number Part Description Contour Rod Template Polyaxial Screw Driver Polyaxial Head Breaker Polyaxial Screw Countersink Inline Rod Persuader Inline Rod Persuader Knob Gibralt Rod Rocker 16

19 INDICATIONS FOR USE GENERAL DESCRIPTION The Gibralt Spine System is a posterior system intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical, and/ or upper thoracic spine. The system consists of a variety of sizes of rods, hooks, poly-axial screws and connecting components, which can be rigidly locked to the rod in various configurations. The Gibralt Spine System components are manufactured from titanium alloy per ASTM F136. This system can be used independently or in conjunction with ChoiceSpine 5.5mm or 6.0mm rodbased Thoraco-Lumbar Pedicle Screw Systems. The 5.5mm or 6.0mm rod-based Pedicle Screw systems are not covered by these instructions for use. Reference the instructions for use accompanying the Pedicle Screw System components for complete instructions for use. INDICATIONS FOR USE When intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spine System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/ or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine. The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Polyaxial screws are not intended to be placed in the cervical spine. This system can be used independently or in conjunction with ChoiceSpine 5.5mm or 6.0mm rodbased Thoraco-Lumbar Pedicle Screw Systems. CONTRAINDICATIONS FOR USE Contraindications include, but are not limited to: Presence of overt infectious process or significant risk of infection (immunocompromise) Signs of local inflammation Fever or leukocytosis Morbid obesity Pregnancy Mental illness Grossly distorted anatomy caused by congenital abnormalities Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count, or a marked left shift in the white blood count differential count Suspected or documented metal allergy or intolerance Rapid joint disease, bone absorption, osteopenia, osteomalacia and/or osteoporosis. Osteoporosis or osteopenia is a relative contraindication since this condition may limit the degree of obtainable correction, stabilization, and/or the amount of mechanical fixation Any patient unwilling to follow postoperative instructions Any case not needing a bone graft and fusion Any case where the implant components selected for use would be too large or too small to achieve a successful result Any case that requires the mixing of metals from two different components or systems Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance Presence of any neural or vascular deficit or other compromising pathology, which may be further injured by device intervention Any case not described in the indications WARNINGS AND PRECAUTIONS The Gibralt Spine System should only be implanted by experienced spine surgeons with specific training in the use of this spine system because this is a technically demanding procedure presenting a risk of serious injury to the patient. In addition, the surgeon should consider the levels of implantation, patient weight, patient activity level, and other patient conditions (e.g., smoking, occupation), which may impact on the performance of the system. The Gibralt Spine System has not been evaluated for safety and compatibility in the MR environment. The Gibralt Spine System has not been tested for heating or migration in the MR environment. 17

20 GIBRALT OCCIPITAL PLATE The Gibralt Spinal System is a comprehensive solution for posterior stabilization and fusion of the cervical and thoracic spine. Offering exceptional versatility and ease-of-use, the Gibralt Spinal System features top-loading polyaxial screws, hooks, offset connectors and rod-to-rod connectors that can be constructed into a multitude of configurations based on individual patient anatomy. 18

Cutting the Rod 6 Contouring the Rod 7 Rod Insertion 8

21 OPERATIVE TECHNIQUE OVERVIEW 1 Contouring the Plate 2 Plate Holder Drilling 3 Tapping 4 Screw Insertion 5 Cutting the Rod 6 Contouring the Rod 7 Rod Insertion 8 Tightening of the Articulating Rod 9 Final Tightening 19

DETAILED OPERATIVE TECHNIQUE SELECTION AND PLACEMENT OF THE OCCIPITAL PLATE The Gibralt Posterior Cervical Thoracic Spinal Fixation System offers an Occipital Plate for occipital fixation.

Figure 1 Occipital Plate Attach the Plate Holder/Drill Guide to the occipital plate and place the plate against the occiput. The Occipital plate should lie smoothly against the bone.

CONTOUR THE PLATE An Occipital Plate Bender is available to contour the occipital plate for proper seating against the occiput.

22 DETAILED OPERATIVE TECHNIQUE SELECTION AND PLACEMENT OF THE OCCIPITAL PLATE The Gibralt Posterior Cervical Thoracic Spinal Fixation System offers an Occipital Plate for occipital fixation. The Occipital Plate is available in two sizes (Small mm, and large 35-45mm). Each Occipital Plate has two sliding connecting points for the rods and 5 holes for fixation (Figure 1). Figure 1 Occipital Plate Attach the Plate Holder/Drill Guide to the occipital plate and place the plate against the occiput. The Occipital plate should lie smoothly against the bone. It may be necessary to smooth irregular protrubences of the bone slightly while ensuring that significant portions of the cortical bone remain, especially in areas where the screw will be inserted. CONTOUR THE PLATE An Occipital Plate Bender is available to contour the occipital plate for proper seating against the occiput. Slide the Occipital Plate Bender over the plate and apply pressure in the appropriate bend areas to achieve the desired contour with the patient s anatomy. To maintain the integrity of the plate, it should only be bent in one direction (Figure 2). NOTE: Reverse bending of the plates is not recommended. DRILL Using the Plate Holder/Drill Guide with the appropriate Fixed Depth insert, place the occipital plate against the occiput in the desired position (Figure3a). Using the 3.2mm Adjustable Drill, drill the first pilot hole into the most superior fixation hole of the plate. Depth of the pilot hole may be confirmed via use of the Depth Gauge. Figure 2 Contouring the Plate Note: The Plate Holder / Drill Guide Insert must be removed to allow for proper seating of the Depth Gauge, then returned prior to Tapping. The pilot hole is then tapped with a 4.5mm Tap (Figure3b). Figure 3a Plate Holder Figure 3b Plate Holder Drilling 20

Figure 4 Tapping CENTER LINE SCREW INSERTION After both screw holes have been drilled and tapped through the Plate Holder/Drill Guide Insert, remove the Insert and choose the screw that corresponds

23 TAP Due to the thickness of the occipital bone, it is recommended that the bone is fully tapped prior to the insertion of the screw. Place the appropriate size Fixed Depth Insert into the Plate Holder/Drill Guide and insert the 4.5mm Tap through and tap to appropriate depth (Figure 4). Figure 4 Tapping CENTER LINE SCREW INSERTION After both screw holes have been drilled and tapped through the Plate Holder/Drill Guide Insert, remove the Insert and choose the screw that corresponds with the pre drilled depth. The two inferior screws may be inserted through the Plate Holder/Drill Guide, and into the bone using the Occipital Screw Driver. The screws should be inserted fully until they are flush with the plate (Figure 5). It is recommended that a minimum of the three center line screws be utilized for Occipital Plate fixation. Upper plate screws are to be positioned with the aid of the Fixed Depth Drill/Tap Guides. Using the 3.2mm Drill, drill the pilot hole through the Drill/ Tap Guide and the desired fixation hole on the plate (Figure 6a). Depth of the pilot hole may be confirmed by using the Depth Gauge. Figure 6a Drill Figure 5 Screw Insertion Then, insert the 4.5mm Tap through the Fixed Depth Drill/Tap Guide and tap to appropriate depth. Remove the Drill/Tap Guide and choose the screw that corresponds with the pre-drilled depth. Insert the screw through the Occipital Plate, and into the bone using the Occipital Screw Driver. The screw should be inserted fully until it is flush with the plate. If desired, the two remaining screws should be inserted following the technique described above (Figure 6b). CUT AND CONTOUR THE ROD The Rod may be placed with the articulating joint in a cephalad or caudal position based upon the patient anatomy and surgeon preference. Cut and contour the occipital rod so that it lies smoothly against the posterior surface of the occiput and inserts easily into any of the hooks and polyaxial screws. Figure 6b Screw Insertion 21

The final length of the rod should extend approximately 2-4mm from the occipital fixation points. If desired, the Contour Rod Template may be used to measure the desired length of the rod.

Figure 7a Cutting the Rod To contour the rod, place the Contour Rod Template along the identified path through the hooks and screws matching the anatomy or desired curve.

24 The final length of the rod should extend approximately 2-4mm from the occipital fixation points. If desired, the Contour Rod Template may be used to measure the desired length of the rod. Mark where to cut the rod, insert it into the opening of the Rod Cutter and then squeeze the handles to cut the rod (Figure 7a & b). Figure 7a Cutting the Rod To contour the rod, place the Contour Rod Template along the identified path through the hooks and screws matching the anatomy or desired curve. Use the French Bender to contour the rods by placing the rod in the French Bender and squeezing the handles to achieve the desired curvature (Figure 8). ROD INSERTION Initial Articulating Rod Placement (C3-T3) should be initiated through the Gibralt CT Spinal System Operative Technique. Align Occipital end of the Articulating Rod into the tulip of the Occipital Plate with the Rod Holder Forceps (Figure 9). Figure 7b Cut Rod If additional rod contouring is desired, secure the rod with the In-situ Benders and gently contour until the desired radius is achieved. SET SCREW INSERTION Using the Set Screw Starter, insert the set screw into the tulip of the Occipital Plate and loosely tighten in a clockwise motion. While the rod is held in place, the set screws are provisionally tightened using the Set Screw Driver attached to the desired Handle. Figure 9 Rod Insertion Figure 8 Contouring the Rod 22

Figure 10 Initial Tightening of the Articulating Rod Figure 11 Final Tightening of the Rod INTIAL TIGHTENING OF THE ARTICULATING ROD Once the set screws have been placed, perform the initial

Hold Articulating Rod Wrench still on the fixed joint and tighten by advancing the loose nut with the Articulating Torque Wrench until the torque wrench audibly breaks over (Figure 11).

25 Figure 10 Initial Tightening of the Articulating Rod Figure 11 Final Tightening of the Rod INTIAL TIGHTENING OF THE ARTICULATING ROD Once the set screws have been placed, perform the initial tightening of the rod joint by using the Articulating Rod Wrench and Articulating Rod Torque Wrench (Figure 10). Hold Articulating Rod Wrench still on the fixed joint and tighten by advancing the loose nut with the Articulating Torque Wrench until the torque wrench audibly breaks over (Figure 11). Repeat on the second rod. FINAL TIGHTENING Prior to Occipital Plate Tightening, ensure that proper anatomical alignment is set. To perform final tightening of the construct, insert the Screw Driver attached to the T-Handle Torque Driver through the Counter Torque and turn the T-Handle Torque Driver clockwise until the Torque Driver audibly clicks. Repeat on the second occipital tulip (Figure 12). Figure 12 Final Tightening REMOVAL To remove the Occitipital Plate, attach the Screw Driver to the desired Handle and turn counter clockwise to remove the set screws. Next, remove the rod by lifting it up out of the construct. To remove the occipital screws, place the Occipital Screw Driver into the head of the screws and turn counter clockwise until screws are removed from the bone. The plate may now be lifted off of the occiput. 23

IMPLANT LISTING Catalog Number Part Description 05-008-00-0000 Occipital Plate 25mm to 35mm 05-008-01-0000 Occipital Plate 35mm to 45mm 05-000-07-4506 05-000-07-4508 05-000-07-4510 05-000-07-4512

26 IMPLANT LISTING Catalog Number Part Description Occipital Plate 25mm to 35mm Occipital Plate 35mm to 45mm Gibralt Occipital Screw 4.5x6mm Gibralt Occipital Screw 4.5x8mm Gibralt Occipital Screw 4.5x10mm Gibralt Occipital Screw 4.5x12mm Gibralt Occipital Screw 4.5x14mm Gibralt Occipital Screw 4.5x16mm Gibralt Occipital Screw 5.0 x 6mm Gibralt Occipital Screw 5.0 x 8mm Gibralt Occipital Screw 5.0 x 10mm Gibralt Occipital Screw 5.0 x 12mm Gibralt Occipital Screw 5.0 x 14mm Gibralt Occipital Screw 5.0 x 16mm Articulating Rod-Occipital INSTRUMENT LISTING Catalog Number Part Description mm Flexible Tap mm Tap mm Flexible Drill Bit mm Drill Bit Flexible Screw Driver Occipital Plate Bender Counter Torque Flexible Shaft Occipital Drill Guide Flexible Set Screw Starter Angled Screw Driver Torque Limiting Wrench Articulating Rod 24

27 IMPLANT LISTING Wrench Articulating Rod mm Fixed Insert, Plate Holder/Drill Guide 8mm Fixed Insert, Plate Holder/Drill Guide 10mm Fixed Insert, Plate Holder/Drill Guide 12mm Fixed Insert, Plate Holder/Drill Guide 14mm Fixed Insert, Plate Holder/Drill Guide Fixed Drill Guide, 6mm x 8mm Fixed Drill Guide, 10mm x 12mm Fixed Drill Guide, 14mm x 16mm INDICATIONS FOR USE INDICATIONS FOR USE When used with the Gibralt Spine System, the Gibralt Occipital Spine System is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3). The Gibralt Occipital Spine System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/dislocation, occipital-cervical dislocation, atlantoaxial fracture with instability, failed previous fusion and/or tumors. The Occipital Bone Screws are limited to occipital fixation only. The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Polyaxial screws are not intended to be placed in the cervical spine. CONTRAINDICATIONS FOR USE Contraindications include, but are not limited to: Presence of overt infectious process or significant risk of infection (Immunocompromise) Signs of local inflammation Fever of leukocytosis Morbid obesity Pregnancy Mental Illness Severe comminuted fractures, such that segments may not be maintained in satisfactory proximate reduction Grossly distorted anatomy caused by congenital abnormalities Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count, or a marked left shift in the white blood count differential count Suspected or documented metal allergy or intolerance Rapid joint disease, bone absorption, osteopenia, osteomalacia and/or osteoporosis. Osteoporosis or osteopenia is a relative contraindication since this condition may limit the degree of obtainable correction, stabilization, and/or the amount of mechanical fixation Any patient unwilling to follow postoperative instructions Any case not needing a bone graft and fusion Any case that requires the implant components selected for use would be too large or too small to achieve a successful result Any case that requires the mixing of metals from two different components or systems Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance Presence of any neural or vascular deficient or other compromising pathology, which may be further injured by device intervention Any case not described in the indications WARNINGS AND PRECAUTIONS The Gibralt Occipital Spine System should only be implanted by experienced spine surgeons with specific training in the use of this spine system because this is a technically demanding procedure presenting a risk of serious injury to the patient. In addition, the surgeon should consider the levels of implantation, patient weight, patient activity level, and other patient conditions (e.g., smoking, occupation), which may impact on the performance of the system. The Gibralt Occipital Spine System has not been tested for safety and compatibility in the MR environment. The Gibralt Occipital Spine System has not been tested for heating or migration in the MR environment. 25

28 ChoiceSpine, Inc. is proud to have offices and distributors around the globe. For more information about ChoiceSpine products available in your country, please visit For additional device information, refer to the ChoiceSpine-Instructions for Use for a device description, indications, contraindications, precautions and warnings. For further product information, please contact Customer Service, ChoiceSpine, 400 Erin Drive Knoxville, TN (865) , FAX (865) This Gibralt Operative Technique has been developed in cooperation with Ronald Moskovich, MD and Erich Richter, MD. ChoiceSpine, Inc. as the manufacturer of this device, does not practice medicine, and is not responsible for recommending the appropriate surgical technique for use on a particular patient. These guidelines are intended to be solely informational and each surgeon must evaluate the appropriateness of these guidelines based on his or her personal medical training and experience. Prior to use of this system, the surgeon should refer to the product package insert for comprehensive warnings, precautions, indications for use, contraindications and adverse effects. The products discussed herein may be available under different trademarks in different countries. All copyrights, and pending and registered trademarks, are property of ChoiceSpine, Inc. This material is intended for the sole use and benefit of the ChoiceSpine sales force and physicians. It should not be redistributed, duplicated or disclosed without the express written consent of ChoiceSpine, Inc ChoiceSpine, Inc LIT # Gibralt STG Rev 01 6/17

BLACKBIRD Spinal System

BLACKBIRD Spinal System Cervical-Thoracic Spinal Fixation System The ChoiceSpine BLACKBIRD Cervical-Thoracic Spinal Fixation System is a comprehensive system for posterior ﬁxation of the cervical and upper