MATRIX Spine System Degenerative. A posterior pedicle screw and rod fixation system.

Transcription

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

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3 Table of Contents Introduction MATRIX Spine System Degenerative 2 AO Principles 6 Indications and Contraindication 7 Surgical Technique Pedicle Screw Insertion 8 Rod Insertion 12 Locking Cap Insertion 16 Distraction and Compression 17 Final Tightening 18 Locking Cap Loosening 19 Optional Techniques 22 Product Information How to Disassemble Instruments for Cleaning 31 Implants 33 Instruments 36 Set Lists 43 Image intensifier control Synthes

4 MATRIX Spine System Degenerative. A posterior pedicle screw and rod fixation system. The MATRIX Spine System Degenerative is a comprehensive thoracolumbar pedicle screw system designed to provide flexibility, biomechanical performance and a total solution to complex posterior pathological challenges. The system is composed of pedicle screws, preassembled polyaxial pedicle screws, locking caps, transconnectors, rods, and polyaxial head implants. 2 Synthes MATRIX Spine System Degenerative Technique Guide

5 Polyaxial Pedicle Screw* Dual-core, double-lead thread 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 50º 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 polyaxial head, allowing instruments to be easily attached and removed from the implant. ±25 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 3

6 MATRIX Spine System Degenerative. A posterior pedicle screw 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 Polyaxial Heads The polyaxial head of the implant is designed for 50 of angulation. To ease intraoperative planning, the polyaxial heads can be removed and replaced without removing the bone screw from the pedicle. Standard and reduction heads incorporate features to easily mate with rod reduction instrumentation. 4 Synthes MATRIX Spine System Degenerative Technique Guide

7 Rods 5.5 mm diameter. Offered in titanium alloy (Ti-6Al-7Nb) and cobalt chromium (CoCr)*. Available in curved or precut lengths to help ease intraoperative construct assembly and technique maneuvers. Available in a variety of lengths from 30 mm to 125 mm. * Also available Synthes 5

8 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 Degenerative Technique Guide

9 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 7

10 Surgical Technique Note: The following technique applies to these indications: Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) Trauma (i.e., fracture or dislocation) Deformities or curvatures (i.e., scoliosis, kyphosis, and/ or lordosis, Scheuermann s Disease) Tumor Stenosis Failed previous fusion (pseudoarthrosis) The technique for spondylolisthesis reduction is covered on page 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 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. 8 Synthes MATRIX Spine System Degenerative Technique Guide

11 Alternative instruments Ratchet Palm Grip Handle, 6 mm quick coupling 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 Curved Probe with Palm Handle See page 32 for a detailed list * Also available Synthes 9

12 Surgical Technique 2 Insert pedicle and/or polyaxial pedicle screws Instruments Holding Sleeve, long Sport Grip T25 StarDrive Shaft, long 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. Notes: Polyaxial screwheads must remain free and mobile after insertion to allow accurate alignment to the rod during locking cap insertion and final tightening. If posterior interbody fusion will be performed at an affected level, please refer to the Optional Technique for Distraction for Posterior Interbody Fusion (page 26). 10 Synthes MATRIX Spine System Degenerative Technique Guide

13 Alternative instruments Holding Sleeve, standard T25 StarDrive Shaft, standard * T-Handle T25 StarDrive Shaft, standard Sport Grip T25 StarDrive Shaft, standard T25 StarDrive Shaft, long * T-Handle T25 StarDrive Shaft, long Ratchet T-Handle, 6 mm quick coupling * Ratchet Sport Grip Handle, 6 mm quick connect * Also available Synthes 11

14 Surgical Technique 3 Determine rod length Instruments Polyaxial Head Alignment Tool Coated Rod Template, for 5.5 mm rods, 150 mm To determine the contour of the rod, use the coated rod template. The rod template has graduations in 10 mm increments to determine the desired length. Note: Use the polyaxial head alignment tool to confirm that the head is still mobile and free from surrounding anatomy prior to inserting the rod. Select precontoured rod. 4 Rod placement and reduction Instruments Rod Holding Forceps, for 5.5 mm rods * Table Top Rod Cutter and Bender * Handheld Rod Cutter Use the rod holding forceps to insert the rod into the openings of the top-loading screws. If necessary, the following instruments can aid with rod reduction. 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 12 Synthes MATRIX Spine System Degenerative Technique Guide

15 Option A: Rod reduction with a rod pusher Instruments Rod Pusher Countertorque, standard Detachable Handle Seat the rod into the screw using 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 instruments Rod Pusher Countertorque, long Rod Pusher, for 5.5 mm/6.0 mm rods Option B: Rod reduction with a rocker fork Instruments Small MATRIX Rocker Fork Footed MATRIX Rocker Fork Use a small MATRIX rocker fork to lever the rod into the head of the pedicle screw. 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 Synthes 13

16 Surgical Technique 4. Rod placement and reduction continued 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. The ratchet will hold the persuader in the reduced position while the locking cap is applied. Insert and tighten the locking cap. 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 14 Synthes MATRIX Spine System Degenerative Technique Guide

17 Option D: Rod reduction with a threaded persuader Instruments mm Hex Drive Adapter MATRIX Threaded Persuader, standard Ratchet Palm Grip Handle, 6 mm quick coupling 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 palm ratchet 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 Synthes 15

18 Surgical Technique 5 Insert locking cap Instruments Sport Grip T25 StarDrive Shaft, standard Rod Pusher Countertorque, standard Detachable Handle Insert a Sport Grip 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, it will drop slightly into the head of the implant. Thread the locking cap clockwise into 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 to the rod where it passes 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 8). 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 connect * Also available 16 Synthes MATRIX Spine System Degenerative Technique Guide

19 6 Distract Instruments Distraction Forceps * T-Handle T25 StarDrive Shaft, long Use the distraction forceps to distract the construct. Once in the desired position, provisionally tighten the locking caps with a T25 StarDrive screwdriver. Once the desired distraction is achieved at all levels of the construct, final tighten each locking cap as described in Step 8. The rod holding forceps can be used as a temporary point of distraction when adjacent pedicle screws are too distant. Optional instrument Rod Holding Forceps, for 5.5 mm rods 7 Compress Instruments Compression Forceps * T-Handle T25 StarDrive Shaft, long Use the compression forceps to compress the construct. Once in the desired position, provisionally tighten the locking caps with a T25 StarDrive screwdriver. Once the desired compression is achieved at all levels of the construct, final tighten each locking cap as described in Step 8. The rod holding forceps can be used as a temporary point of compression when adjacent pedicle screws are too distant. Optional instrument Rod Holding Forceps, for 5.5 mm rods * Also available Synthes 17

20 Surgical Technique 8 Perform final tightening Instruments Nm Torque Limiting Ratchet Handle, 6 mm hex coupling T25 StarDrive Shaft, standard Countertorque for T25, standard Detachable Handle Place the countertorque over the head of the screw. 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 lock ing 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. Optional instruments Rod Pusher Countertorque, standard MATRIX Threaded Persuader, standard MATRIX Simple Persuader, standard Rod Pusher Countertorque, long MATRIX Threaded Persuader, long MATRIX Simple Persuader, long Countertorque for T25, long If there is difficulty in loosening the locking cap, refer to Step 9. 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. 18 Synthes MATRIX Spine System Degenerative Technique Guide

21 9 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 19

22 Surgical Technique 9. Locking cap loosening (optional) 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. 20 Synthes MATRIX Spine System Degenerative Technique Guide

23 Option B: Locking cap loosening/ removal on adjacent screw Instruments Nm Torque Limiting Ratchet Handle T25 StarDrive Shaft, standard Countertorque, for T25, standard Rod Pusher Countertorque 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 8) on all screws in which a countertorque load has been applied. Synthes 21

24 Optional Techniques Unassembled pedicle screw insertion Instruments 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 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. 22 Synthes MATRIX Spine System Degenerative Technique Guide

25 Retrieve a polyaxial head from the implant module, by aligning the head placement tool to the rod slot features on the implant and press down. 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 distal 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. Synthes 23

26 Optional Techniques Polyaxial head removal Instruments Tab Removal Tool Head Removal Tool Ratchet Palm Grip Handle, 6 mm quick coupling 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. 24 Synthes MATRIX Spine System Degenerative Technique Guide

27 Reduction screw insertion Instruments Holding Sleeve, standard * T-Handle T25 StarDrive Shaft, standard 15 mm reduction Reduction Sleeve Countertorque Reduction Crown Tab Removal Tool Follow the Optional Technique for Unassembled Pedicle Screw Insertion to prepare pedicles, place pedicle screws, and attach polyaxial head implants. 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. Synthes 25

28 Optional Techniques Reduction screw insertion continued 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. Place the countertorque over the screwhead and final tighten each locking cap to the required torque of 10 Nm (Step 8 of the surgical technique). Repeat for each reduction head. Alternative technique using the reduction crown. * Also available 26 Synthes MATRIX Spine System Degenerative Technique Guide

29 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 designed to increase rotational stability of the construct. 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 27

30 Optional Techniques Spondylolisthesis reduction Instruments mm Hex Drive Adapter MATRIX Threaded Persuader, standard Ratchet T-Handle, 6 mm quick coupling Ratchet Palm Grip Handle, 6 mm quick coupling Insert polyaxial pedicle screws, rods and locking caps in the adjacent and affected vertebrae as described in Steps 1 through 4 of the surgical technique. Place locking caps in the polyaxial heads of the cranial and caudal vertebrae. Tighten the caudal locking caps only. 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 palm ratchet 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. 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 countertorque. Alternative instrument MATRIX Threaded Persuader, long Reduction travel: 30 mm 28 Synthes MATRIX Spine System Degenerative Technique Guide

31 Distraction for posterior interbody fusion Instruments * T-Handle T25 StarDrive Shaft, long Distractor Tip Threaded Distractor Tip Detachable Holding Sleeve MATRIX Distractor Rack Footed Distractor Tip If posterior interbody fusion is performed, the distractor rack may be used to distract the interbody disc space. Retract the green knob while sliding the sleeve toward the handle on the screwdriver shaft until it stops. Slide the distractor tip over the screwdriver tip and press firmly into the detachable holding sleeve. Place the screwdriver tip firmly into the T25 StarDrive recess of the polyaxial or pedicle screw and rotate the green knob clockwise. Firmly tighten to secure the pedicle screw to the screwdriver. Insert pedicle screws in the pedicles adjacent to the segment requiring distraction. To release the detachable holding sleeve from the distractor tip, retract the green knob toward the handle. Remove the screwdriver and holding sleeve. Repeat for the adjacent pedicle screw. Insert both posts of the distractor into the distractor tips. Lock the angular position of the rotatable distractor arm by turning the lever clockwise. If necessary, switch the drive lever to the distraction position [DISTR] and rotate the wing nut clockwise until the desired distraction is achieved. Perform discectomy and interbody fusion. * Also available Synthes 29

32 Optional Techniques Distraction for posterior interbody fusion continued Alternative distractor tips and techniques Three different distractor tips are offered to assist in distracting a pair of vertebrae; standard, footed, and threaded. Shown are a variety of combinations for distracting. The footed distractor tip can be used with pedicle, polyaxial, and reduction polyaxial screws (Figure 1). Shown is a footed distractor tip positioned in a polyaxial screw combined with a standard distractor tip in a pedicle screw. Figure 1 The threaded distractor tip can be used with polyaxial and reduction polyaxial screws (Figure 2). Shown is a threaded distractor tip positioned in a polyaxial screw combined with a standard distractor tip in a pedicle screw. The standard distractor tip can be used with pedicle, polyaxial, and reduction polyaxial screws (Figure 3). Shown are two standard distractor tips positioned in a pedicle screw and polyaxial screw. Figure 2 Figure 3 30 Synthes MATRIX Spine System Degenerative Technique Guide

33 How to Disassemble Instruments for Cleaning Screwdriver with Holding Sleeve Screwdriver with Detachable Holding Sleeve Countertorque Synthes 31

34 How to Disassemble Instruments for Cleaning Polyaxial Head Placement Tool Head Removal Tool Torque Limiting Handle MATRIX Threaded Persuader 32 Synthes MATRIX Spine System Degenerative Technique Guide

35 Implants Titanium MATRIX Locking Cap Titanium MATRIX Top Loading Polyaxial Head Titanium Polyaxial Reduction Head Synthes 33

36 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 55 mm thread lengths mm Titanium MATRIX Polyaxial Screws mm 65 mm thread lengths mm Titanium MATRIX Polyaxial Screws mm 55 mm thread lengths mm Titanium MATRIX Screws mm 45 mm thread lengths mm Titanium MATRIX Screws mm 55 mm thread lengths mm Titanium MATRIX Screws mm 65 mm thread lengths mm Titanium MATRIX Screws mm 65 mm thread lengths mm Titanium MATRIX Screws mm 55 mm thread lengths * For additional diameters and lengths, refer to also available product listing at the end of this guide. 34 Synthes MATRIX Spine System Degenerative Technique Guide

37 Rods 5.5 mm Titanium Curved Rods Length (mm) Length (mm) mm Precontoured Rods (Co-28Cr-6Mo)* Length (mm) Length (mm) 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 * Also available Synthes 35

38 Instruments For pedicle preparation Taps for Dual Core Screws, 6 mm hex coupling * 3.5 mm mm (shown) mm * 5.5 mm mm mm mm mm Ball Tip Probes Straight (shown) Curved Probes with Palm Handle Pedicle, for 4.0 mm and 4.2 mm screws (shown) Straight Curved Awl with Palm Handle * Also available 36 Synthes MATRIX Spine System Degenerative Technique Guide

39 For screw insertion Holding Sleeves Standard (shown) Long T25 StarDrive Shafts Standard (shown) Long T-Handle T25 StarDrive Shafts * Standard (shown) * Long Sport Grip T25 StarDrive Shafts Standard (shown) Long Distractor Tip Distractor Tip, threaded * Also available Synthes 37

40 Instruments For screw insertion continued Detachable Holding Sleeve Footed Distractor Tip Ratchet T-Handle, 6 mm quick coupling Ratchet Sport Grip Ratchet Handle, 6 mm quick connect Ratchet Palm Grip Handle, 6 mm quick coupling 38 Synthes MATRIX Spine System Degenerative Technique Guide

41 For rod insertion Rod Holding Forceps, for 5.5 mm rods Rod Pusher, for 5.5 mm/6.0 mm rods Coated Rod Template, for 5.5 mm rods, 150 mm For polyaxial heads Polyaxial Head Alignment Tool Polyaxial Head Placement Tool Head Removal Tool Reamer Synthes 39

42 Instruments For distraction and compression Forceps Compression (shown) Distraction Detachable Holding Sleeve MATRIX Distractor Rack 40 Synthes MATRIX Spine System Degenerative Technique Guide

43 For cap introduction and tightening Nm Torque Handle Rod Pusher Countertorques Standard (shown) Long Countertorques for T Standard (shown) Long Detachable Handle For transconnectors 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 41

44 Instruments For rod reduction MATRIX Threaded Persuaders Standard (shown) Long MATRIX Simple Persuaders Standard (shown) Long MATRIX Rocker Forks Small Footed (shown) Reduction Sleeve Countertorque Reduction Crown Tab Removal Tool 42 Synthes MATRIX Spine System Degenerative Technique Guide

45 MATRIX Titanium Polyaxial Pedicle Screw Set, Preassembled and Unassembled ( ) consists of: MATRIX Titanium Preassembled Polyaxial Pedicle Screw Set MATRIX Titanium Unassembled Polyaxial Pedicle Screw Set consists of: Graphic Case, for Titanium MATRIX Polyaxial Screws 4.0 mm Titanium MATRIX Polyaxial Screws Thread Length (mm) Qty mm Titanium MATRIX Polyaxial Screws Thread Length (mm) Qty mm Titanium MATRIX Polyaxial Screws Thread Length (mm) Qty mm Titanium MATRIX Polyaxial Screws Thread Length (mm) Qty mm Titanium MATRIX Polyaxial Screws Thread Length (mm) Qty 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 DJ1304 Synthes 43

46 MATRIX Titanium Polyaxial Pedicle Screw Set, Preassembled and Unassembled ( ) consists of: Graphic Case, for Titanium MATRIX Pedicle Screws 4.0 mm Titanium MATRIX Screws Thread Length (mm) Qty mm Titanium MATRIX Screws Thread Length (mm) Qty mm Titanium MATRIX Screws Thread Length (mm) Qty mm Titanium MATRIX Screws Thread Length (mm) Qty mm Titanium MATRIX Screws Thread Length (mm) Qty Synthes MATRIX Spine System Degenerative Technique Guide

47 MATRIX Degenerative Instrument and Titanium Implant Set ( ) consists of: MATRIX Instrument Set for Screw Placement MATRIX Instrument Set for Rod Reduction MATRIX Instrument Set for Pedicle Preparation MATRIX Instrument and Titanium Implant Set MATRIX Long Instrument Set consists of: Graphic Case, for Basic MATRIX Instruments Nm Torque Limiting Ratchet Handle, 6 mm hex coupling Holding Sleeve, standard, 2 ea T25 StarDrive Shaft, standard, 2 ea Sport Grip T25 StarDrive Shaft, standard Polyaxial Head Alignment Tool Holding Sleeve, long, 2 ea T25 StarDrive Shaft, long, 2 ea Sport Grip T25 StarDrive Shaft, long Detachable Handle, 2 ea Distractor Tip, 2 ea Threaded Distractor Tip, 2 ea Detachable Holding Sleeve, 2 ea MATRIX Distractor Rack, 2 ea Footed Distractor Tip, 2 ea Ratchet T-Handle, 6 mm quick coupling, 2 ea. Synthes 45

48 MATRIX Degenerative Instrument and Titanium Implant Set ( ) consists of: Graphic Case, for Auxilliary Basic MATRIX Instruments Compression Forceps Distraction Forceps mm Hex Drive Adapter Rod Pusher Countertorque, standard MATRIX Threaded Persuader, standard, 2 ea MATRIX Simple Persuader, standard Small MATRIX Rocker Fork Footed MATRIX Rocker Fork Countertorque for T25, standard Rod Holding Forceps, for 5.5 mm rods Ratchet Palm Grip Handle, 6 mm quick coupling Rod Pusher, for 5.5 mm/6.0 mm rods consists of: Graphic Case, for MATRIX Pedicle Preparation Instruments Ratchet Palm Grip Handle, 6 mm quick coupling Taps for Dual Core Screws, 6 mm hex coupling mm mm mm mm mm mm Pedicle Probe with Palm Handle, for 4.0 mm and 4.2 mm screws Straight Ball Tip Probe Curved Ball Tip Probe Palm Ratchet Handle Probe with Palm Handle Awl with Palm Handle Curved Probe with Palm Handle 46 Synthes MATRIX Spine System Degenerative Technique Guide

49 consists of: Graphic Case, for Instruments and Titanium MATRIX Implants mm Setscrew Extractor, square coupling, 2 ea Extender, 6 mm hex coupling Reduction Sleeve Countertorque Reduction Crown, 2 ea Tab Removal Tool Polyaxial Head Placement Tool, 2 ea Head Removal Tool Reamer 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 Titanium MATRIX Locking Cap, 20 ea Titanium MATRIX Top Loading Polyaxial Head, 20 ea. Titanium Snap-On Transconnectors, 2 ea 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 Polyaxial Reduction Head, 6 ea Coated Rod Template, for 5.5 mm rods, 150 mm 5.5 mm Titanium Curved Rods Length (mm) Qty Synthes 47

50 MATRIX Degenerative Instrument and Titanium Implant Set ( ) consists of: Graphic Case, for Auxilliary Long Basic MATRIX Instruments Rod Pusher Countertorque, long MATRIX Threaded Persuader, long, 2 ea MATRIX Simple Persuader, long Palm Handle, fixed Countertorque for T25, long 48 Synthes MATRIX Spine System Degenerative Technique Guide

51 Also Available 7.0 mm Titanium MATRIX Polyaxial Screws Thread Length (mm) mm Titanium MATRIX Polyaxial Screws Thread Length (mm) mm Titanium MATRIX Screws Thread Length (mm) mm Precontoured Rods (Co-28Cr-6Mo) Length (mm) Length (mm) mm Titanium MATRIX Polyaxial Screws Thread Length (mm) mm Titanium MATRIX Screws Thread Length (mm) mm Titanium MATRIX Screws Thread Length (mm) Synthes

52 Synthes Spine 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) Fax: (610) Synthes (Canada) Ltd Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) To order: (800) Fax: (905) Synthes, Inc. or its affiliates. All rights reserved. Axon, CerviFix, Click X, Pangea and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 3/11 J9699-C