MATRIX Spine System Deformity. A posterior pedicle screw, hook, and rod fixation system.

Transcription

1 MATRIX Spine System Deformity. A posterior pedicle screw, hook, and rod fixation system. Technique Guide Instruments and implants approved by the AO Foundation

2

3 Table of Contents Introduction MATRIX Spine System Deformity 2 AO Principles 8 Indications and Contraindications 9 Surgical Technique Pedicle Screw Insertion 10 Hook Insertion 15 Rod Insertion 17 Locking Cap Insertion 23 Deformity Correction 24 Distraction and Compression 26 Final Tightening 28 Locking Cap Loosening 29 Optional Techniques 32 Product Information How to Disassemble Instruments for Cleaning 39 Implants 41 Instruments 46 Set Lists 56 Image intensifier control Synthes

4 MATRIX Spine System Deformity. A posterior pedicle screw, hook and rod fixation system. The MATRIX Spine System Deformity is a comprehensive thoracolumbar pedicle screw system designed to provide flexibility, biomechanical performance and a solution to complex posterior pathological challenges. The system is composed of pedicle screws, preassembled polyaxial pedicle screws, monoaxial screws, hooks, locking caps, transconnectors, rods, and polyaxial head implants. Tab Removal Tool Reduction Screw Hook 2 Synthes MATRIX Spine System Deformity Technique Guide

5 T25 StarDrive Shaft Snap-on Transconnector Polyaxial Head 5.5 mm CoCr Hex-End Rod Monoaxial Screw Polyaxial Screw Synthes 3

6 MATRIX Spine System Deformity. A posterior pedicle screw, hook and rod fixation system. Polyaxial Pedicle Screw* Dual-core, double-lead thread (8 mm 9 mm, single lead) is designed to securely anchor the screw implants in both the cortical and cancellous bony anatomy. Threaded T25 StarDrive recess is designed to deliver torque efficiently and effectively, even under high load applications. The inner thread provides a low-profile connection for instrumentation, delivering visibility and implant rigidity. Allows up to 50 of angulation to ease in situ connection to the longitudinal rod. The low-profile polyaxial head minimizes the implant height above the bony anatomy. The polyaxial head strength has been designed to withstand derotation, reduction, and free-hand tightening maneuvers. The rod reduction features are located at the top of the monoaxial head, allowing instruments to be easily attached and removed from the implant. ±25 ±25 Monoaxial Pedicle Screw* Dual-core, double-lead thread design (8 mm 9 mm, single lead) is optimized to securely anchor the screw implants in both the cortical and cancellous bony anatomy. The inner thread provides a low-profile connection for instrumentation, delivering visibility and implant rigidity. The low-profile head minimizes the implant height above the bony anatomy. The rod reduction features are raised to the top of the polyaxial head, allowing instruments to be easily attached and removed from the implant. * Data on file at Synthes. 4 Synthes MATRIX Spine System Deformity Technique Guide

7 Hooks* Wide array of hooks for various patient anatomy. The low-profile head minimizes the implant height above the bony anatomy. The rod reduction features are located at the top of the hook, allowing instruments to be easily attached and removed from the implant. Locking Cap* Square thread design minimizes cross threading under high reduction loads and off-axis techniques. The saddle on the underside of the locking cap has a groove and ridge geometry to maximize resistance to rod push-through. The concave shape saddles the rod, preventing it from skiving during rod reduction. The saddle s design also pilots the locking cap to the polyaxial head and rod, minimizing cross threading. Self-retaining T25 StarDrive recess designed to resist damage at high loads. * Data on file at Synthes. Synthes 5

8 MATRIX Spine System Deformity. A posterior pedicle screw, hook and rod fixation system. Transconnector The snap-on transconnector is a preassembled implant; no in situ assembly required, only final positioning and tightening. Telescoping body is arched to accommodate grafts and anatomical structures; allows the transconnector to span over a range of lengths (Figure 1). The locking screws use a T15 StarDrive which minimizes drive stripping while final tightening. The jaws of the transconnector swivel and are spring-loaded (Figure 2). The swivel joints allow the jaws to quickly find the correct orientation to each rod (Figures 3 and 4). The spring-loaded jaw feature automatically applies a tensioning load to the implant, allowing it to remain stationary until final tightening. Figure 1 Figure 2 Figure 3 Figure 4 Rods 5.5 mm diameter. Offered in three different materials: titanium, titanium alloy (Ti-6Al-7Nb), and cobalt chromium. Available in straight, precontoured, and hex-end types to ease intraoperative construct assembly and technique maneuvers. Available in a variety of lengths from 200 mm to 500 mm. Tapered Rods 6.0 mm diameter tapered to 5.5 mm diameter. 5.5 mm diameter tapered to 4.0 mm diameter (titanium alloy only). 5.5 mm diameter tapered to 3.5 mm diameter (titanium alloy only) (shown). Offered in titanium alloy (Ti-6Al-7Nb), titanium or cobalt chromium. Available in 500 mm length. 6 Synthes MATRIX Spine System Deformity Technique Guide

9 Polyaxial Heads To ease intraoperative planning, the polyaxial heads can be removed and replaced without removing the bone screw from the pedicle (Figures 1a and b). The polyaxial head of the implant is designed for 50 of angulation. Standard and reduction heads incorporate features to easily mate with rod reduction instrumentation. Figure 1a Figure 1b Open Titanium Transverse Bars Provide a lateral extension from the longitudinal rod to the monoaxial screw. Available in lengths of 15 mm, 20 mm, 25 mm, and 30 mm. Eliminate the need for severe rod contours which might otherwise be required for direct hook or screw-to-rod connection. Synthes 7

10 AO Principles In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation. 1 They are: Anatomic reduction Stable internal fixation Preservation of blood supply Early, active mobilization The fundamental aims of fracture treatment in the limbs and fusion of the spine are the same. A specific goal in the spine is returning as much function as possible to the injured neural elements. 2, 3 1. M.E. Müller, M. Allgöwer, R. Schneider, and H. Willenegger: Manual of Internal Fixation, 3rd Edition. Berlin; Springer- Verlag Ibid. 3. M. Aebi, J.S. Thalgott, and J.K. Webb. AO ASIF Principles in Spine Surgery. Berlin; Springer -Verlag Synthes MATRIX Spine System Deformity Technique Guide

11 Indications and Contraindications Indications The Synthes USS are noncervical spinal fixation devices intended for posterior pedicle screw fixation (T1 S2/ ilium), posterior hook fixation (T1 L5), or anterolateral fixation (T8 L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann s Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When treating patients with degenerative disc disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct. When used with the 3.5 mm/6.0 mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm Systems. In addition, when used with 3.5 mm/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5 mm Systems. When used with the 5.0 mm/6.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 3.5 mm/6.0 mm and 4.0 mm/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5 mm and 4.0 mm/5.5 mm tapered rods, MATRIX can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the MATRIX System. In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes USS 6.0 mm rod systems: USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click X, Click X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix 5.5 mm rod system: MATRIX 5.0 mm rod system: USS Small Stature CerviFix 3.5 mm rod systems: CerviFix, Axon, Synapse 4.0 mm rod system: Synapse Contraindications Use of these devices is contraindicated when there is active systemic infection, infection localized to the site of the proposed implantation, or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials. Severe osteoporosis may prevent adequate fixation and thus preclude the use of this or any other orthopaedic implant. Conditions that may place excessive stresses on bone and implants, such as severe obesity or degenerative diseases, are relative contraindications. The decision whether to use these devices in patients with such conditions must be made by the physician taking into account the risks versus the benefits to the patients. Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions, thereby placing undue stresses on the implant during bony healing. This could result in a higher risk of implant failure. When treating patients with degenerative disc disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct. Please refer to package insert (GP2774) for the full list of warnings and precautions. Synthes 9

12 Surgical Technique 1 Prepare pedicles and determine screw lengths Instruments Probe with Palm Handle Awl with Palm Handle Locate pedicles and use the awl to perforate the cortex. Use the appropriate probe to open the pedicle canal. Using radiographic imaging, confirm pedicle location, orientation and depth by inserting the probe. When selecting the appropriate length screw, use the markings on the probe to determine the pedicle depth. All MATRIX pedicle screws are self-tapping; however, if tapping is preferred, use the appropriate tap and tap handle. Alternative instruments Thoracic Pedicle Probe Small Thoracic Pedicle Probe Pedicle Marker Pedicle Marker Inserter Taps, for Dual Core Screws, 6 mm hex coupling (3.5 mm 9.0 mm) Pedicle Probe with Palm Handle, for 4.0 mm and 4.2 mm screws Straight Ball Tip Probe Curved Ball Tip Probe Straight Ball Tip Probe, small Palm Ratchet Handle Curved Probe with Palm Handle 10 Synthes MATRIX Spine System Deformity Technique Guide

13 2 Insert screws Option A: Insert monoaxial pedicle screws Instruments Sport Grip T25 StarDrive Shaft, standard Holding Sleeve, for MATRIX Monoaxial To assemble the monoaxial screwdriver, slide the finger spring (etched part C) onto the T25 StarDrive shaft. Next, slide the holding sleeve onto the T25 StarDrive shaft. Turn the finger spring clockwise to engage the thread within the gray knob. Part C Note: Remove the finger sleeve and retract the tube and tip for cleaning and sterilization. Synthes 11

14 Surgical Technique 2. Insert screws Option A: Insert monoaxial pedicle screws continued Insert the assembled screwdriver into the head of the appropriate monoaxial pedicle screw. The holding sleeve provides rigid coupling by threading into the head of the pedicle screw. Insert and thread the monoaxial screw into the prepared pedicle. The black outer sleeve of the holding sleeve is designed to rotate freely and can be held firmly to help maintain a desired trajectory. To release the sleeve from the screw, turn the gray knob counterclockwise and remove the screwdriver. Note: Do not grasp the gray knob during screw insertion as this will cause the holding sleeve to disengage from the screw. Repeat for each screw. Alternative instruments T25 StarDrive Shaft, standard Sport Grip T25 StarDrive Shaft, standard * Holding Sleeve, long, for MATRIX Monoaxial T25 StarDrive Shaft, long * T-Handle T25 StarDrive Shaft, long * Sport Grip T25 StarDrive Shaft, long Ratchet T-Handle, 6 mm quick coupling * Ratchet Sport Grip Handle, 6 mm quick connect * Also available 12 Synthes MATRIX Spine System Deformity Technique Guide

15 Option B: Insert polyaxial pedicle screws Instruments Holding Sleeve, standard Sport Grip T25 StarDrive Shaft, standard To assemble the polyaxial screwdriver, retract the green knob distally, then slide the sleeve toward the handle of the screwdriver shaft until it stops. Notes: Disassemble completely for cleaning. Do not grasp the green knob during screw insertion as this will cause the holding sleeve to disengage from the screw. Place the screwdriver tip securely into the T25 StarDrive recess of the polyaxial pedicle screw and rotate the green knob of the holding sleeve clockwise. Firmly tighten to secure the implant. Insert and thread the polyaxial pedicle screw into the prepared pedicle. The black portion of the holding sleeve is designed to rotate freely and can be held firmly to help maintain a desired trajectory. To release the sleeve, rotate the green knob counterclockwise and remove the screwdriver. Repeat for each pedicle screw. Note: Polyaxial screwheads must remain free and mobile after insertion to allow accurate alignment to the rod during locking cap insertion and final tightening. Synthes 13

16 Surgical Technique 2. Insert screws Option B: Insert polyaxial screws continued Alternative instruments T25 StarDrive Shaft, standard Sport Grip T25 StarDrive Shaft, standard * Holding Sleeve, long T25 StarDrive Shaft, long * T-Handle T25 StarDrive Shaft, long * Sport Grip T25 StarDrive Shaft, long Ratchet T-Handle, 6 mm quick coupling * Ratchet Sport Grip Handle, 6 mm quick connect * Also available 14 Synthes MATRIX Spine System Deformity Technique Guide

17 3 Prepare for hook Option A: Prepare lamina for lamina hook Instruments Small Lamina Finder Large Lamina Finder Using the appropriate lamina finder, separate the ligamentum flavum from the underside of the lamina to ensure good bony contact with the lamina hook. Option B: Prepare pedicle for pedicle hook Instrument Pedicle Finder Using the pedicle finder, open the facet capsule and locate the pedicle. Remove a small piece of the inferior articular process to ensure proper seating of the pedicle hook. Pedicle hooks should be placed in an up-going direction only. Option C: Prepare transverse process for transverse process hook Instrument Transverse Process Finder Use the transverse process finder to separate the intertransverse ligament from the underside of the transverse process. Synthes 15

18 Surgical Technique 4 Insert hook Instruments MATRIX Hook Holding Forceps, lateral MATRIX Hook Holding Forceps, straight MATRIX Hook Holding Forceps, curved MATRIX Hook Positioner/ Pusher Attach the desired hook to the appropriate MATRIX hook holding forceps. Place the hook in the desired location. The MATRIX hook positioner/pusher may also be used to facilitate placement of the hook. Place remaining hooks by repeating Steps 3 and 4 as determined in the preoperative plan. 16 Synthes MATRIX Spine System Deformity Technique Guide

19 5 Determine rod contour and length Instruments Polyaxial Head Alignment Tool Coated Rod Template, 150 mm, for 5.5 mm rods Coated Rod Template, 500 mm, for 5.0 mm/ 5.5 mm rods To determine the contour of the rod, use the appropriate coated rod template. The rod template has graduations in 10 mm increments to determine the desired length. To adjust the alignment of the screwheads, use the polyaxial head alignment tool. Note: Ensure the polyaxial head alignment tool is seated into the head. Use tool to confirm that the head is still mobile and free from surrounding anatomy prior to inserting the rod. Select rod. Synthes 17

20 Surgical Technique 6 Contour and cut rod Instrument Rod Bender Alternative instruments * Pipe Benders, with long handles In Situ Bender, right, for 5.5 mm rods In Situ Bender, left, for 5.5 mm rods Coronal Rod Bender, left, for 5.5 mm rods Coronal Rod Bender, right, for 5.5 mm rods * Table Top Rod Cutter and Bender * Handheld Rod Cutter Contour the rod to match the rod template, using the rod bender. Alternatively, in situ benders, coronal benders, or pipe benders may be used to contour the rod. Notes: When cutting CoCr rods, a closed-head rod cutter must be used, such as the handheld rod cutter or the table top rod cutter and bender. Do not reverse bend rods. Reverse bending may produce internal stresses which may become the focal point for eventual breakage of the implant. * Also available 18 Synthes MATRIX Spine System Deformity Technique Guide

21 7 Rod placement and reduction Instrument Rod Holder, for 5.5 mm/6.0 mm rods Use the rod holder to insert the rod into the openings of the top-loading screws or hooks. If necessary, the following instruments can aid with rod reduction. Alternative instrument * Rod Holding Forceps, for 5.5 mm rods Option A: Rod reduction with a rod pusher Instruments Rod Pusher Countertorque, standard Detachable Handle Rod Pusher, for 5.5 mm/6.0 mm rods Seat the rod into the screw or hook, using the rod pusher for 5.5 mm/6.0 mm rods or the standard rod pusher countertorque. The detachable handle connects easily to the octagonal end of the rod pusher countertorque, providing an adjustable L-handle to apply downward force on the rod. Alternative instrument * Rod Pusher Countertorque, long Note: When using a tapered rod, it is important not to position the transition taper within the head of a screw or hook. * Also available Synthes 19

22 Surgical Technique 7. Rod placement and reduction continued Option B: Rod reduction with a rocker fork Instruments Small MATRIX Rocker Fork Footed MATRIX Rocker Fork Medium MATRIX Rocker Fork Use a medium rocker fork to lever the rod into the head of the pedicle screw or hook. Technique tip: Use the footed MATRIX rocker fork to aid in reducing the rod into adjacent screwheads. Reduction travels: Small MATRIX Rocker Fork = 8.5 mm Footed MATRIX Rocker Fork = 7.5 mm Medium MATRIX Rocker Fork = 13 mm 20 Synthes MATRIX Spine System Deformity Technique Guide

23 Option C: Rod reduction with a simple persuader Instrument MATRIX Simple Persuader, standard Ensure that the ratchet handle is fully open, then place the simple persuader over the implant head and press down firmly until the tips engage the head of the implant. Squeeze the handle to seat the rod into the head of the pedicle screw or hook. When the rod is fully reduced, a black line will appear at the proximal end of the simple persuader. The ratchet will hold the persuader in the reduced position while the locking cap is applied. Prior to inserting and tightening the locking cap, ensure proper tool alignment. The simple persuader can be used as a countertorque during final tightening. To remove, squeeze handles then press the ratchet release located between the handles of the simple persuader. Once the handles return to the fully open position, twist the handles slightly to disengage the reduction tube and lift to remove. Alternative instrument MATRIX Simple Persuader, long Reduction travel: 15 mm Synthes 21

24 Surgical Technique 7. Rod placement and reduction continued Option D: Rod reduction with a threaded persuader Instruments mm Hex Drive Adapter MATRIX Threaded Persuader, standard Palm Ratchet Handle Before placing the threaded persuader over the head of the implant, ensure that the reduction tube is fully extended. Check that the black line on the threaded persuader is visible and at the 30 mm graduation located on the outer tube of the persuader. Align the slotted tips of the inner reduction tube over the rod and press onto the screwhead. Load the hex adapter into the ratcheting T-handle. Insert the adapter into the top of the persuader handle. While holding the green handle of the threaded persuader stationary, use the ratchet with adapter to advance the black nut clockwise and gradually reduce the screw to the rod. When the rod is fully seated, the black line on the reduction tube will be at the 0 mm graduation located on the outer tube of the persuader. Insert and tighten the locking cap. The threaded persuader can be used as a countertorque during final tightening. To remove, fully retract until the black line is exposed, then lift away. Note: Disassemble completely for cleaning and sterilization. Alternative instrument MATRIX Threaded Persuader, long Technique tip: The threaded persuader includes an alternative L-handle attachment that can be used to aid in holding the threaded persuader when used as a countertorque. Reduction travel: 30 mm 22 Synthes MATRIX Spine System Deformity Technique Guide

25 8 Insert locking cap Instruments Sport Grip T25 StarDrive Shaft, standard Rod Pusher Countertorque, standard Detachable Handle Insert the standard T25 StarDrive shaft tip firmly into the locking cap and remove the locking cap from the graphic case. When the cap is axially aligned to the screwhead or hook, it will drop slightly into the head of the implant. Thread the locking cap clockwise into the head of the implant and tighten to a light provisional torque. To ensure optimal cap alignment, use the rod pusher countertorque. Ensure optimal saddle-to-rod contact by minimizing bends directly through the implant head. Repeat for each locking cap. Note: Ensure the required torque is applied to each locking cap by using the torque limiting handle and following the instructions for final tightening (Step 14). Alternative instruments T25 StarDrive Shaft, standard T-Handle T25 StarDrive Shaft, standard T25 StarDrive Shaft, long * T-Handle T25 StarDrive Shaft, long * Sport Grip T25 StarDrive Shaft, long * Rod Pusher Countertorque, long Ratchet T-Handle, 6 mm quick coupling * Ratchet Sport Grip Handle, 6 mm quick coupling * Also available Synthes 23

26 Surgical Technique 9 Correct deformity with in situ bending (optional) Instruments In Situ Bender, right, for 5.5 mm rods In Situ Bender, left, for 5.5 mm rods Coronal Rod Bender, left, for 5.5 mm rods Coronal Rod Bender, right, for 5.5 mm rods Use the in situ benders to contour the rod in the sagittal plane. The coronal benders can be used to contour the rod in the coronal plane. 10 Correct deformity with rod rotation (optional) If rod rotation is desired, the following options may be used. Ensure that the rod is captured with the locking cap, but is free to rotate within the head of the pedicle screw or hook. Option A: Rod holder for 5.5 mm/6.0 mm rods Instruments T-Handle T25 StarDrive Shaft, standard Sport Grip T25 StarDrive Shaft, standard Rod Holder, for 5.5 mm/6.0 mm rods Use the rod holder for 5.5 mm/6.0 mm rods to grasp the rod and slowly rotate it in the proper direction. Use either the T-handle or sport grip shaft to tighten the locking caps after achieving the desired rod rotation. 24 Synthes Spine MATRIX Spine System Deformity Technique Guide

27 Option B: Hex-end rods and rod rotation wrench Instruments T-Handle T25 StarDrive Shaft, standard Sport Grip T25 StarDrive Shaft, standard Rod Rotation Wrench, for 5.5 mm/6.0 mm hex-end rods If hex-end rods are used in the construct, the rod rotation wrench for 5.5 mm/6.0 mm hex-end rods can be applied to the hex end of the rod to rotate. Use either the T-handle or sport grip shaft to tighten the locking caps after achieving the desired rod rotation. 11 Correct deformity with derotation (optional) Instruments T-Handle T25 StarDrive Shaft, standard Derotation Tube * Sport Grip T25 StarDrive Shaft, long If a derotation maneuver is desired, ensure that the locking caps are not tightened. Place a derotation tube over each selected screw. Use the tubes as leverage to maneuver the vertebral bodies. Insert either the T-handle or sport grip shaft through the tubes to tighten the locking caps. * Also available Synthes 25

28 Surgical Technique 12 Distract Instruments Distractor Fork T-Handle T25 StarDrive Shaft, standard Sport Grip T25 StarDrive Shaft, standard Parallel Distractor, for 5.5 mm/6.0 mm rods Rod Holder, for 5.5 mm/6.0 mm rods When implants are too close together, the distractor fork can be used to open space between the screwheads to begin distraction. Use the rod holder for 5.5 mm/6.0 mm rods as a point of fixation against which to distract. Use the parallel distractor for 5.5 mm/6.0 mm rods to distract the construct. Once in the desired position, tighten the locking caps with either the T-handle or sport grip shaft. 26 Synthes MATRIX Spine System Deformity Technique Guide

29 13 Compress Instruments T-Handle T25 StarDrive Shaft, standard Sport Grip T25 StarDrive Shaft, standard Parallel Compressor, for 5.5 mm/6.0 mm rods Rod Holder, for 5.5 mm/6.0 mm rods Two Level Parallel Compressor, for 5.5 mm/ 6.0 mm rods Use the rod holder for 5.5 mm/6.0 mm rods as a fixed point on the rod to compress the construct. Once in the desired position, tighten the locking screws with either the T-handle or sport grip shaft. Use the two level parallel compressor if compression is required across multiple levels. Synthes 27

30 Surgical Technique 14 Perform final tightening Instruments Nm Torque Limiting Ratchet Handle T25 StarDrive Shaft, standard Countertorque for T25, standard Detachable Handle Place the countertorque over the head of the screw or hook. Attach the T25 StarDrive shaft to the torque limiting handle and insert the shaft through the countertorque cannula and into the drive recess of the locking cap. Tighten until there is a tactile release which indicates that the required 10 Nm of torque has been applied. Repeat for all locking caps. Warnings: Final tightening of the locking caps should only be performed with a calibrated, Synthes 10 Nm torque handle. MATRIX screw implants achieve performance standard only when tightened to the required 10 Nm tightening torque. Refer to the torque limiting handle package and labeling for the recommended calibration maintenance. Notes: To ensure optimal construct locking, repeat final tightening sequence. If a locking cap needs to be loosened or removed after having been tightened to 10 Nm, use a countertorque and solid screwdriver shaft with torque limiting handle. If there is difficulty in loosening the locking cap, refer to Step 15. Alternative instruments Rod Pusher Countertorque, standard MATRIX Threaded Persuader, standard MATRIX Simple Persuader, standard T25 StarDrive Shaft, long * Rod Pusher Countertorque, long MATRIX Threaded Persuader, long MATRIX Simple Persuader, long * Countertorque for T25, long Caution: Never use a fixed or ratcheting T-handle screwdriver for this technique. If the torque limiting attachment is not used, breakage of the driver may occur and could potentially harm the patient. * Also available 28 Synthes MATRIX Spine System Deformity Technique Guide

31 15 Locking cap loosening (optional) Instruments Nm Torque Limiting Ratchet Handle T25 StarDrive Shaft, standard Countertorque, for T25, standard Detachable Handle If a locking cap needs to be loosened after tightened to 10 Nm, use a countertorque with detachable handle, MATRIX screwdriver shaft, and a 10 Nm torque limiting handle to loosen the locking cap. Note: Locking caps are designed to lock the construct and resist postoperative loosening and rod push through. Therefore, in certain cases, the loosening torque may be higher than 10 Nm. In such cases, apply the following technique to loosen a locking cap. Place the torque handle in the neutral position and begin to sequentially tighten and then immediately loosen the locking cap. Turn until tactile or audible feedback from the implants is experienced. It is important to approach the torque limit of the handle, but not exceed through the limit. Repeat the tightening/ loosening steps until the locking cap is loose. To ensure the screwdriver shaft is protected from damage, always use the 10 Nm torque limiting handle. Caution: Never use a fixed or ratcheting T-handle screwdriver for this technique. If the torque limiting attachment is not used, breakage of the driver may occur and could potentially harm the patient. Synthes 29

32 Surgical Technique 15. Locking cap loosening continued If after multiple attempts to loosen the locking cap the torque is still excessive, one of the following techniques should be used: Option A: Locking cap loosening/removal with simple persuader Instruments Nm Torque Limiting Ratchet Handle T25 StarDrive Shaft, standard MATRIX Simple Persuader, standard If after multiple attempts to loosen the locking cap the torque is still excessive, apply a downward force on the rod. Place the MATRIX simple persuader on the screw and firmly squeeze the handles with two hands. With the reduction load applied begin to sequentially tighten and then immediately loosen the locking cap. Turn until tactile or audible feedback from the implants is experienced. It is important to approach the torque limit of the handle, but not exceed through the limit. Repeat the tightening/loosening steps until the locking cap is loose. To ensure the screwdriver shaft is protected from damage, always use the 10 Nm torque limiting handle. Caution: Never use a fixed or ratcheting T-handle screwdriver for this technique. If the torque limiting attachment is not used, breakage of the driver may occur and could potentially harm the patient. 30 Synthes MATRIX Spine System Deformity Technique Guide

33 Option B: Locking cap loosening/ removal on adjacent screw Instruments Nm Torque Limiting Ratchet Handle T25 StarDrive Shaft, standard Rod Pusher Countertorque Countertorque, for T25, standard Detachable Handle Place the rod pusher countertorque with detachable handle over an adjacent screw on the same rod (i.e., one level higher or lower). Simultaneously place the countertorque, for T25, standard over the locking cap to be loosened and engage the screwdriver shaft and torque limiting handle with the StarDrive recess of the locking cap. Place the torque handle in the neutral position and begin to sequentially tighten and then immediately loosen the locking cap. Turn until tactile or audible feedback from the implants is experienced. It is important to approach the torque limit of the handle, but not exceed through the limit. Repeat the tightening/loosening steps until the locking cap is loose. To ensure the screwdriver shaft is protected from damage, always use the 10 Nm torque limiting handle. Caution: Never use a fixed or ratcheting T-handle screwdriver for this technique. If the torque limiting attachment is not used, breakage of the driver may occur and could potentially harm the patient. Note: Be sure to perform final tightening sequence (see Step 14) on all screws in which a countertorque load has been applied. Synthes 31

34 Optional Techniques Reduction screw insertion Instruments Nm Torque Limiting Ratchet Handle Holding Sleeve, standard 15 mm reduction T-Handle T25 StarDrive Shaft, standard Reduction Sleeve Countertorque, for MATRIX Reduction Screws Reduction Crown Tab Removal Tool Countertorque for T25, standard Detachable Handle Following polyaxial pedicle screw insertion (Step 2, Option B), release the holding sleeve by turning the green knob counterclockwise and removing the screwdriver. ±25 32 Synthes MATRIX Spine System Deformity Technique Guide

35 Place the rod into the head of each screw. Either the reduction sleeve or the reduction crown must be placed on the implant tabs to maintain proper thread engagement during rod reduction. Begin reducing the rod by threading the locking cap into the reduction screwhead. Once the rod is fully reduced, remove the reduction sleeve or the reduction crown. After the locking cap is fully seated, place the countertorque for reduction screws over the screwhead. Use the tab removal tool to break off the reduction screw tabs. Slide the tab removal tool over one side wall of the reduction head. Gently rock the tab removal tool toward the center of the screw to break the tab wall free from the polyaxial head. Repeat for each reduction head tab. Place the countertorque over the screwhead and final tighten each locking cap to the required torque of 10 Nm (Step 14). Synthes 33

36 Optional Techniques Unassembled pedicle screw insertion Instruments T-Handle T25 StarDrive Shaft, standard Polyaxial Head Placement Tool Reamer Prepare the pedicle and insert pedicle screws as recommended in Steps 1 and 2 of the surgical technique. Prepare the site for the MATRIX polyaxial head. Insert the reamer over the implanted bone screw. Rotate to remove all interfering bone and to ensure enough space exists to allow free mobility of the polyaxial head. Repeat for each pedicle screw. To retrieve a polyaxial head from the implant module with the head placement tool, align rod slot features on the tool and implant and press down firmly. 34 Synthes MATRIX Spine System Deformity Technique Guide

37 Position the placement tool with the polyaxial head over the MATRIX bone screw and press down onto the screwhead. To ensure the polyaxial head is securely attached to the bone screw, gently lift up on the placement tool and angulate the polyaxial head. To release the head placement tool from the polyaxial head, press the button located on the proximal end of the instrument. Note: If the polyaxial head does not successfully attach to the head of the bone screw, additional reaming or screw height adjustment may be required to ensure sufficient space exists to allow free mobility of the head. Technique tip: Pull up on the polyaxial head placement tool to ensure the head is attached securely. Synthes 35

38 Optional Techniques Polyaxial head removal Instruments Tab Removal Tool Head Removal Tool Ratchet Palm Grip Handle, 6 mm quick coupling Palm Ratchet Handle If required, the polyaxial head can be removed intraoperatively from the pedicle screw. This provides surgeons with the ability to change polyaxial heads without removing the pedicle screw. To remove the polyaxial head, it is necessary to remove the locking cap and rod. Attach the palm ratchet handle to the quick coupling located on the proximal end of the head removal tool. Slide the inner shaft into the handle of the head removal tool and thread clockwise until the black line is visible but flush with the back end of the green silicone handle. Press the tip of the head removal tool into the polyaxial head to be removed. A tactile click may be felt as the tip of the head removal tool mates with the collet of the polyaxial head. While holding the green silicone handle, thread the inner shaft clockwise until it stops. Lift to remove the head. Repeat for each polyaxial head to be removed. Note: The head removal tool can be used to remove the standard polyaxial head of an unassembled or preassembled screw. To remove the polyaxial reduction head, the tabs must first be removed with the tab removal tool. 36 Synthes MATRIX Spine System Deformity Technique Guide

39 Adding transconnectors Instruments Holding Sleeve, for Snap-On Transconnectors Locking StarDrive Screwdriver Shaft, T15, short, quick coupling Transconnector Caliper Nm Torque Limiting Handle, 4.5 mm quick coupling The snap-on transconnector is used to increase rotational stability. Use the transconnector caliper to measure the distance between the two rods and note the reference number located on the back of the caliper scale (1 8). The transconnectors are labeled 1 8, corresponding with the scale on the caliper. Select the indicated transconnector of the appropriate length. The open jaws of the transconnector have a snap-on feature to retain the desired location on the rod. Use the T15 StarDrive screwdriver shaft with the 3.0 Nm torque limiting handle to secure the transconnector to the rods. After engaging the T15 drive into each setscrew recess, slide the retractable centering sleeve to the distal position. Tighten the setscrews on each end and in the center until a tactile release is felt. Notes: If any part of the construct requires further adjustment, all transconnector setscrews must be loosened to the point of resistance. Do not remove setscrews from the assembly. After final adjustment, retighten the setscrews. The MATRIX transconnector contains Nitinol components. Implants that contain Nitinol should not be used in patients with nickel sensitivities or allergies. Warning: Refer to the torque limiting handle package and labeling for the recommended calibration maintenance. Synthes 37

40 Optional Techniques Transverse bar attachment (monoaxial only) The transverse bar provides an extension to the monoaxial screw in situations where the rod contour or patient anatomy prevents a direct screw-to-rod connection. Instruments Locking Star Drive Screwdriver Shaft, T15, short, quick coupling Rod Pusher, for 5.5 mm/6.0 mm rods Nm Torque Limiting Handle, 4.5 mm quick coupling Place the opening of the transverse bar over the 5.5 mm rod. Loosely attach the transverse bar to the rod by tightening the setscrew with the T15 StarDrive screwdriver shaft and 3.0 Nm torque limiting handle. Introduce the transverse bar into the screw opening. Use the rod pusher for 5.5 mm/6.0 mm rods. Secure the transverse bar to the screw by inserting the locking cap and tighten, following locking cap final tightening procedure (refer to Step 8 of the surgical technique). Secure the transverse bar to the rod using the T15 StarDrive screwdriver shaft and 3.0 Nm torque limiting handle. Tighten the setscrew firmly until a tactile release is felt. Warning: Final tightening of the setscrew should only be performed with a calibrated Synthes 3 Nm torque handle. Refer to the torque limiting handle package and labeling for the recommended calibration maintenance. 38 Synthes MATRIX Spine System Deformity Technique Guide

41 How to Disassemble Instruments for Cleaning Screwdriver with Monoaxial Holding Sleeve Screwdriver with Holding Sleeve Countertorque Polyaxial Head Placement Tool Synthes 39

42 How to Disassemble Instruments for Cleaning Head Removal Tool Torque Limiting Handle for T15 Setscrews Threaded Persuader 40 Synthes MATRIX Spine System Deformity Technique Guide

43 Implants Titanium MATRIX Locking Cap Titanium MATRIX Top Loading Polyaxial Head Titanium Polyaxial Reduction Head Synthes 41

44 Implants Screws mm Titanium MATRIX Polyaxial Screws mm 45 mm thread lengths mm Titanium MATRIX Polyaxial Screws mm 55 mm thread lengths mm Titanium MATRIX Polyaxial Screws mm 60 mm thread lengths mm Titanium MATRIX Polyaxial Screws mm 65 mm thread lengths mm Titanium MATRIX Polyaxial Screws mm 100 mm thread lengths mm Titanium MATRIX Polyaxial Screws mm 100 mm thread lengths mm Titanium MATRIX Polyaxial Screws mm 100 mm thread lengths mm Titanium MATRIX Monoaxial Screws mm 45 mm thread lengths mm Titanium MATRIX Monoaxial Screws mm 55 mm thread lengths mm Titanium MATRIX Monoaxial Screws mm 60 mm thread lengths mm Titanium MATRIX Monoaxial Screws mm 65 mm thread lengths mm Titanium MATRIX Monoaxial Screws mm 100 mm thread lengths mm Titanium MATRIX Monoaxial Screws mm 100 mm thread lengths mm Titanium MATRIX Monoaxial Screws mm 100 mm thread lengths mm Titanium MATRIX Reduction Screws mm 45 mm thread lengths 42 Synthes MATRIX Spine System Deformity Technique Guide

45 Rods mm Titanium Hard Precontoured Rod, 80 mm straight length, 400 mm 5.5 mm Titanium Hard Rods mm mm mm mm Titanium Hard Hexagonal-End Rod, 500 mm mm Hexagonal-End Rod, 500 mm (Co-28Cr-6Mo) mm/ 6.0 mm Titanium Hard Tapered Rod, 500 mm mm/ 6.0 mm Titanium Tapered Rod, 500 mm mm/ 5.5 mm Titanium Tapered Rod, 500 mm (shown) mm/ 5.5 mm Titanium Tapered Rod, 500 mm mm/6.0 mm Tapered Rod, 500 mm (Co-28Cr-6Mo) Synthes 43

46 Implants Transconnectors Telescoping Range Caliper Reference Number mm 22 mm mm 26 mm mm 31 mm mm 33 mm mm 38 mm mm 47 mm mm 62 mm mm 90 mm 8 44 Synthes MATRIX Spine System Deformity Technique Guide

47 Hooks Titanium MATRIX Lamina Hooks Extra Small Small Medium Large Small, Straight (shown) Large, Straight Thoracic Medium, Tall Body Large, Tall Body Offset right Offset left Up-Angled Down-Angled Titanium MATRIX Pedicle Hooks Small Medium (shown) Titanium MATRIX Transverse Process Hooks Right (shown) Left Transverse bars Titanium MATRIX Transverse Bars mm (shown) mm mm mm Synthes 45

48 Instruments For pedicle preparation Thoracic Pedicle Probe Small Thoracic Pedicle Probe Pedicle Marker Pedicle Marker Inserter Pedicle Probe with Palm Handle, for 4.0 mm and 4.2 mm screws Awl with Palm Handle 46 Synthes MATRIX Spine System Deformity Technique Guide

49 Taps for Dual Core Screws, 6 mm hex coupling mm mm (shown) mm mm mm mm mm mm Ball Tip Probes Straight (shown) Curved Straight, small For screw insertion Holding Sleeves Standard (shown) For MATRIX Monoaxial * Long, for MATRIX Monoaxial * Long T25 StarDrive Shafts Standard (shown) Long T-Handle T25 StarDrive Shafts Standard (shown) * Long * Also available Synthes 47

50 Instruments For screw insertion continued Sport Grip T25 StarDrive Shafts Standard (shown) * Long Ratchet T-Handle, 6 mm quick coupling * Ratchet Sport Grip Handle, 6 mm quick connect Ratchet Palm Grip Handle For polyaxial heads Polyaxial Head Alignment Tool Polyaxial Head Placement Tool * Also available 48 Synthes Spine MATRIX Spine System Deformity Technique Guide

51 Head Removal Tool Reamer For hook placement Lamina Finders Small (shown) Large MATRIX Hook Holding Forceps, lateral MATRIX Hook Holding Forceps, straight MATRIX Hook Holding Forceps, curved Synthes 49

52 Instruments For hook placement continued MATRIX Hook Positioner/ Pusher Pedicle Finder Transverse Process Finder For rod handling and templating Rod Bender Rod Rotation Wrench, for 5.5 mm/ 6.0 mm hex-end rods In Situ Benders, for 5.5 mm rods Right Left 50 Synthes MATRIX Spine System Deformity Technique Guide

53 Coronal Rod Benders, for 5.5 mm rods Left Right * Rod Holding Forceps, for 5.5 mm rods Rod Pusher, for 5.5 mm/6.0 mm rods Rod Holder, for 5.5 mm/6.0 mm rods Coated Rod Templates For 5.5 mm rods, 150 mm (shown) For 5.0 mm/5.5 mm rods, 500 mm * Also available Synthes 51

54 Instruments For rod reduction mm Hex Drive Adapter MATRIX Threaded Persuaders Standard (shown) Long MATRIX Simple Persuaders Standard (shown) Long MATRIX Rocker Forks Small Footed (shown) Medium Reduction Sleeve 52 Synthes MATRIX Spine System Deformity Technique Guide

55 Countertorque, for MATRIX Reduction Screws Reduction Crown Tab Removal Tool For cap introduction and tightening Nm Torque Limiting Ratchet Handle, 6 mm hex coupling Rod Pusher Countertorques Standard (shown) * Long Countertorques for T Standard (shown) * Long Detachable Handle * Also available Synthes 53

56 Instruments For rotation correction Derotation Tube For distraction and compression Distractor Fork Parallel Compressor, for 5.5 mm/ 6.0 mm rods Parallel Distractor, for 5.5 mm/ 6.0 mm rods Two Level Parallel Compressor, for 5.5 mm/ 6.0 mm rods 54 Synthes Spine MATRIX Spine System Deformity Technique Guide

57 For transconnectors and other T15 setscrews Holding Sleeve, for Snap-On Transconnectors Locking StarDrive Screwdriver Shaft, T15, short, quick coupling Transconnector Caliper Nm Torque Limiting Handle, 4.5 mm quick coupling Synthes 55

58 MATRIX Deformity Instrument and Implant Set ( ) Graphic Case Graphic Case, for MATRIX Instruments and Titanium Hooks Instruments Small Lamina Finder Large Lamina Finder MATRIX Hook Holding Forceps, lateral MATRIX Hook Holding Forceps, straight MATRIX Hook Holding Forceps, curved MATRIX Hook Positioner/ Pusher Pedicle Finder Transverse Process Finder Implants Titanium MATRIX Lamina Hooks Extra small, 4 ea Small, 4 ea Medium, 4 ea Large, 4 ea Small straight, 4 ea Large straight, 4 ea Thoracic, 4 ea Medium tall body, 2 ea Large tall body, 2 ea Offset right, 2 ea Offset left, 2 ea Up-angled, 4 ea Down-angled, 4 ea. Titanium MATRIX Pedicle Hooks, 4 ea Small Medium Titanium MATRIX Transverse Process Hooks, 4 ea Transverse right Transverse left Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to or to the below listed inserts, which will be included in the shipping container: Processing Synthes Reusable Medical Devices Instruments, Instrument Trays and Graphic Cases DJ1305 Processing Non-sterile Synthes Implants DJ Synthes MATRIX Spine System Deformity Technique Guide

59 MATRIX Deformity Instrument and Titanium Rod and Cap Set ( ) Graphic Case Graphic Case, for MATRIX Deformity Instruments and Titanium Implants Instruments Polyaxial Head Placement Tool, 2 ea Head Removal Tool Holding Sleeve, for Snap-On Transconnectors Locking StarDrive Screwdriver Shaft, T15, short, quick coupling Transconnector Caliper Nm Torque Limiting Handle, with 4.5 mm quick coupling Implants Titanium MATRIX Locking Cap, 40 ea Titanium MATRIX Top Loading Polyaxial Head, 20 ea. Titanium Snap-On Transconnectors, for 5.5 mm/ 6.0 mm rods mm 22 mm mm 26 mm mm 31 mm mm 33 mm mm 38 mm mm 47 mm mm 62 mm mm 90 mm Titanium MATRIX Transverse Bars mm mm mm mm Titanium Polyaxial Reduction Head, 6 ea. Synthes 57

60 MATRIX Deformity Titanium Monoaxial Screw Set ( ) Graphic Case Graphic Case, for Titanium MATRIX Monoaxial Screws Implants 4.0 mm Titanium MATRIX Monoaxial Screws Thread Length (mm) Qty mm Titanium MATRIX Monoaxial Screws Thread Length (mm) Qty mm Titanium MATRIX Monoaxial Screws Thread Length (mm) Qty mm Titanium MATRIX Monoaxial Screws Thread Length (mm) Qty mm Titanium MATRIX Monoaxial Screws Thread Length (mm) Qty Synthes MATRIX Spine System Deformity Technique Guide