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

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

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

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

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

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

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

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. 1991. 2. Ibid. 3. M. Aebi, J.S. Thalgott, and J.K. Webb. AO ASIF Principles in Spine Surgery. Berlin; Springer -Verlag. 1998. 6 Synthes MATRIX Spine System Degenerative Technique Guide

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

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 25. 1 Prepare pedicles and determine screw lengths Instruments 388.655 Probe with Palm Handle 388.656 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

Alternative instruments 03.632.098 Ratchet Palm Grip Handle, 6 mm quick coupling 03.632.103 Taps for Dual Core Screws, 6 mm hex coupling 03.632.109 (3.5 mm 9.0 mm) 388.536 Pedicle Probe with Palm Handle, for 4.0 mm and 4.2 mm screws 388.545 Straight Ball Tip Probe 388.546 Curved Ball Tip Probe 388.549* Straight Ball Tip Probe, small 388.657 Curved Probe with Palm Handle See page 32 for a detailed list * Also available Synthes 9

Surgical Technique 2 Insert pedicle and/or polyaxial pedicle screws Instruments 03.632.036 Holding Sleeve, long 03.632.075 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

Alternative instruments 03.632.001 Holding Sleeve, standard 03.632.002 T25 StarDrive Shaft, standard 03.632.004* T-Handle T25 StarDrive Shaft, standard 03.632.005 Sport Grip T25 StarDrive Shaft, standard 03.632.072 T25 StarDrive Shaft, long 03.632.074* T-Handle T25 StarDrive Shaft, long 03.632.090 Ratchet T-Handle, 6 mm quick coupling 03.632.091* Ratchet Sport Grip Handle, 6 mm quick connect * Also available Synthes 11

Surgical Technique 3 Determine rod length Instruments 03.632.007 Polyaxial Head Alignment Tool 388.906 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 03.632.081 Rod Holding Forceps, for 5.5 mm rods 388.750* Table Top Rod Cutter and Bender 388.751* 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

Option A: Rod reduction with a rod pusher Instruments 03.632.006 Rod Pusher Countertorque, standard 03.632.080 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 03.632.076 Rod Pusher Countertorque, long 03.632.169 Rod Pusher, for 5.5 mm/6.0 mm rods Option B: Rod reduction with a rocker fork Instruments 03.632.010 Small MATRIX Rocker Fork 03.632.011 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

Surgical Technique 4. Rod placement and reduction continued Option C: Rod reduction with a simple persuader Instrument 03.632.009 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 03.632.079 MATRIX Simple Persuader, long Reduction travel: 15 mm 14 Synthes MATRIX Spine System Degenerative Technique Guide

Option D: Rod reduction with a threaded persuader Instruments 03.620.091 6 mm Hex Drive Adapter 03.632.008 MATRIX Threaded Persuader, standard 03.632.098 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 03.632.078 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

Surgical Technique 5 Insert locking cap Instruments 03.632.005 Sport Grip T25 StarDrive Shaft, standard 03.632.006 Rod Pusher Countertorque, standard 03.632.080 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 03.632.002 T25 StarDrive Shaft, standard 03.632.004* T-Handle T25 StarDrive Shaft, standard 03.632.072 T25 StarDrive Shaft, long 03.632.074* T-Handle T25 StarDrive Shaft, long 03.632.075 Sport Grip T25 StarDrive Shaft, long 03.632.076 Rod Pusher Countertorque, long 03.632.090 Ratchet T-Handle, 6 mm quick coupling 03.632.091* Ratchet Sport Grip Handle, 6 mm quick connect * Also available 16 Synthes MATRIX Spine System Degenerative Technique Guide

6 Distract Instruments 03.620.018 Distraction Forceps 03.632.074* 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 03.632.081 Rod Holding Forceps, for 5.5 mm rods 7 Compress Instruments 03.620.017 Compression Forceps 03.632.074* 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 03.632.081 Rod Holding Forceps, for 5.5 mm rods * Also available Synthes 17

Surgical Technique 8 Perform final tightening Instruments 03.620.061 10 Nm Torque Limiting Ratchet Handle, 6 mm hex coupling 03.632.002 T25 StarDrive Shaft, standard 03.632.049 Countertorque for T25, standard 03.632.080 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 03.632.006 Rod Pusher Countertorque, standard 03.632.008 MATRIX Threaded Persuader, standard 03.632.009 MATRIX Simple Persuader, standard 03.632.076 Rod Pusher Countertorque, long 03.632.078 MATRIX Threaded Persuader, long 03.632.079 MATRIX Simple Persuader, long 03.632.099 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

9 Locking cap loosening (optional) Instruments 03.620.061 10 Nm Torque Limiting Ratchet Handle 03.632.002 T25 StarDrive Shaft, standard 03.632.049 Countertorque, for T25, standard 03.632.080 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

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 03.620.061 10 Nm Torque Limiting Ratchet Handle 03.632.002 T25 StarDrive Shaft, standard 03.632.009 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

Option B: Locking cap loosening/ removal on adjacent screw Instruments 03.620.061 10 Nm Torque Limiting Ratchet Handle 03.632.002 T25 StarDrive Shaft, standard 03.632.049 Countertorque, for T25, standard 03.632.006 Rod Pusher Countertorque 03.632.080 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

Optional Techniques Unassembled pedicle screw insertion Instruments 03.632.037 Polyaxial Head Placement Tool 03.632.046 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

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

Optional Techniques Polyaxial head removal Instruments 03.632.030 Tab Removal Tool 03.632.045 Head Removal Tool 03.632.098 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

Reduction screw insertion Instruments 03.632.001 Holding Sleeve, standard 03.632.004* T-Handle T25 StarDrive Shaft, standard 15 mm reduction 03.632.025 Reduction Sleeve 03.632.026 Countertorque 03.632.029 Reduction Crown 03.632.030 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

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

Adding transconnectors Instruments 03.632.050 Holding Sleeve, for Snap-on Transconnectors 03.632.052 Locking StarDrive Screwdriver Shaft, T15, short, quick coupling 03.632.053 Transconnector Caliper 03.632.204 3.0 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

Optional Techniques Spondylolisthesis reduction Instruments 03.620.091 6 mm Hex Drive Adapter 03.632.008 MATRIX Threaded Persuader, standard 03.632.090 Ratchet T-Handle, 6 mm quick coupling 03.632.098 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 03.632.078 MATRIX Threaded Persuader, long Reduction travel: 30 mm 28 Synthes MATRIX Spine System Degenerative Technique Guide

Distraction for posterior interbody fusion Instruments 03.632.074* T-Handle T25 StarDrive Shaft, long 03.632.083 Distractor Tip 03.632.084 Threaded Distractor Tip 03.632.085 Detachable Holding Sleeve 03.632.087 MATRIX Distractor Rack 03.632.089 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

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

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

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

Implants 04.632.000 Titanium MATRIX Locking Cap 04.632.001 Titanium MATRIX Top Loading Polyaxial Head 04.634.002 Titanium Polyaxial Reduction Head Synthes 33

Implants Screws* 04.632.420 4.0 mm Titanium MATRIX Polyaxial Screws 04.632.445 20 mm 45 mm thread lengths 04.632.520 5.0 mm Titanium MATRIX Polyaxial Screws 04.632.555 20 mm 55 mm thread lengths 04.632.620 6.0 mm Titanium MATRIX Polyaxial Screws 04.632.655 20 mm 55 mm thread lengths 04.632.725 7.0 mm Titanium MATRIX Polyaxial Screws 04.632.765 25 mm 65 mm thread lengths 04.632.835 8.0 mm Titanium MATRIX Polyaxial Screws 04.632.855 35 mm 55 mm thread lengths 04.632.645 04.639.420 4.0 mm Titanium MATRIX Screws 04.639.445 20 mm 45 mm thread lengths 04.639.520 5.0 mm Titanium MATRIX Screws 04.639.555 20 mm 55 mm thread lengths 04.639.620 6.0 mm Titanium MATRIX Screws 04.639.665 20 mm 65 mm thread lengths 04.639.725 7.0 mm Titanium MATRIX Screws 04.639.765 25 mm 65 mm thread lengths 04.639.835 8.0 mm Titanium MATRIX Screws 04.639.855 35 mm 55 mm thread lengths 04.639.645 * 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

Rods 5.5 mm Titanium Curved Rods Length (mm) Length (mm) 04.636.030 30 04.636.065 65 04.636.035 35 04.636.070 70 04.636.040 40 04.636.075 75 04.636.045 45 04.636.080 80 04.636.050 50 04.636.085 85 04.636.055 55 04.636.125 125 04.636.060 60 04.636.070 5.5 mm Precontoured Rods (Co-28Cr-6Mo)* Length (mm) Length (mm) 09.636.030 30 09.636.065 65 09.636.035 35 09.636.070 70 09.636.040 40 09.636.075 75 09.636.045 45 09.636.080 80 09.636.050 50 09.636.085 85 09.636.055 55 09.636.125 125 09.636.060 60 09.636.070 Transconnectors Telescoping Range Caliper Reference Number 04.633.317 17 mm 22 mm 1 04.633.321 21 mm 26 mm 2 04.633.326 26 mm 31 mm 3 04.633.330 30 mm 33 mm 4 04.633.333 33 mm 38 mm 5 04.633.338 38 mm 47 mm 6 04.633.347 47 mm 62 mm 7 04.633.364 62 mm 90 mm 8 * Also available Synthes 35

Instruments For pedicle preparation Taps for Dual Core Screws, 6 mm hex coupling 03.632.103* 3.5 mm 03.632.104 4.0 mm (shown) 03.632.105 5.0 mm 03.632.155* 5.5 mm 03.632.106 6.0 mm 03.632.107 7.0 mm 03.632.108 8.0 mm 03.632.109 9.0 mm Ball Tip Probes 388.545 Straight (shown) 388.546 Curved Probes with Palm Handle 388.536 Pedicle, for 4.0 mm and 4.2 mm screws (shown) 388.655 Straight 388.657 Curved 388.656 Awl with Palm Handle * Also available 36 Synthes MATRIX Spine System Degenerative Technique Guide

For screw insertion Holding Sleeves 03.632.001 Standard (shown) 03.632.036 Long T25 StarDrive Shafts 03.632.002 Standard (shown) 03.632.072 Long T-Handle T25 StarDrive Shafts 03.632.004* Standard (shown) 03.632.074* Long Sport Grip T25 StarDrive Shafts 03.632.005 Standard (shown) 03.632.075 Long 03.632.083 Distractor Tip 03.632.084 Distractor Tip, threaded * Also available Synthes 37

Instruments For screw insertion continued 03.632.085 Detachable Holding Sleeve 03.632.089 Footed Distractor Tip 03.632.090 Ratchet T-Handle, 6 mm quick coupling 03.632.091 Ratchet Sport Grip Ratchet Handle, 6 mm quick connect 03.632.098 Ratchet Palm Grip Handle, 6 mm quick coupling 38 Synthes MATRIX Spine System Degenerative Technique Guide

For rod insertion 03.632.081 Rod Holding Forceps, for 5.5 mm rods 03.632.169 Rod Pusher, for 5.5 mm/6.0 mm rods 388.906 Coated Rod Template, for 5.5 mm rods, 150 mm For polyaxial heads 03.632.007 Polyaxial Head Alignment Tool 03.632.037 Polyaxial Head Placement Tool 03.632.045 Head Removal Tool 03.632.046 Reamer Synthes 39

Instruments For distraction and compression Forceps 03.620.017 Compression (shown) 03.620.018 Distraction 03.632.085 Detachable Holding Sleeve 03.632.087 MATRIX Distractor Rack 40 Synthes MATRIX Spine System Degenerative Technique Guide

For cap introduction and tightening 03.620.061 10 Nm Torque Handle Rod Pusher Countertorques 03.632.006 Standard (shown) 03.632.076 Long Countertorques for T25 03.632.049 Standard (shown) 03.632.099 Long 03.632.080 Detachable Handle For transconnectors 03.632.050 Holding Sleeve, for Snap-On Transconnectors 03.632.052 Locking StarDrive Screwdriver Shaft, T15, short, quick coupling 03.632.053 Transconnector Caliper 03.632.204 3.0 Nm Torque Limiting Handle, 4.5 mm quick coupling Synthes 41

Instruments For rod reduction MATRIX Threaded Persuaders 03.632.008 Standard (shown) 03.632.078 Long MATRIX Simple Persuaders 03.632.009 Standard (shown) 03.632.079 Long MATRIX Rocker Forks 03.632.010 Small 03.632.011 Footed (shown) 03.632.025 Reduction Sleeve 03.632.026 Countertorque 03.632.029 Reduction Crown 03.632.030 Tab Removal Tool 42 Synthes MATRIX Spine System Degenerative Technique Guide

MATRIX Titanium Polyaxial Pedicle Screw Set, Preassembled and Unassembled (01.632.001) 01.632.001 consists of: 01.632.002 MATRIX Titanium Preassembled Polyaxial Pedicle Screw Set 01.632.003 MATRIX Titanium Unassembled Polyaxial Pedicle Screw Set 01.632.002 consists of: 60.632.013 Graphic Case, for Titanium MATRIX Polyaxial Screws 4.0 mm Titanium MATRIX Polyaxial Screws Thread Length (mm) Qty. 04.632.420 20 4 04.632.425 25 4 04.632.428 28 4 04.632.430 30 4 04.632.432 32 4 04.632.435 35 4 04.632.438 38 4 04.632.440 40 4 04.632.445 45 4 5.0 mm Titanium MATRIX Polyaxial Screws Thread Length (mm) Qty. 04.632.520 20 4 04.632.530 30 4 04.632.535 35 4 04.632.540 40 6 04.632.545 45 6 04.632.550 50 4 04.632.555 55 4 6.0 mm Titanium MATRIX Polyaxial Screws Thread Length (mm) Qty. 04.632.620 20 4 04.632.625 25 4 04.632.630 30 6 04.632.635 35 8 04.632.640 40 8 04.632.645 45 8 04.632.650 50 6 04.632.655 55 4 04.632.660 60 4 04.632.665 65 4 7.0 mm Titanium MATRIX Polyaxial Screws Thread Length (mm) Qty. 04.632.725 25 4 04.632.730 30 4 04.632.735 35 4 04.632.740 40 6 04.632.745 45 8 04.632.750 50 8 04.632.755 55 6 04.632.760 60 4 04.632.765 65 4 8.0 mm Titanium MATRIX Polyaxial Screws Thread Length (mm) Qty. 04.632.835 35 2 04.632.840 40 4 04.632.845 45 4 04.632.850 50 4 04.632.855 55 2 Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to http://us.synthes.com/medical+community/cleaning+and+sterilization.htm 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

MATRIX Titanium Polyaxial Pedicle Screw Set, Preassembled and Unassembled (01.632.001) 01.632.003 consists of: 60.632.061 Graphic Case, for Titanium MATRIX Pedicle Screws 4.0 mm Titanium MATRIX Screws Thread Length (mm) Qty. 04.639.420 20 4 04.639.425 25 4 04.639.428 28 4 04.639.430 30 4 04.639.432 32 4 04.639.435 35 4 04.639.438 38 4 04.639.440 40 4 04.639.445 45 4 5.0 mm Titanium MATRIX Screws Thread Length (mm) Qty. 04.639.520 20 4 04.639.530 30 4 04.639.535 35 4 04.639.540 40 6 04.639.545 45 6 04.639.550 50 4 04.639.555 55 4 7.0 mm Titanium MATRIX Screws Thread Length (mm) Qty. 04.639.725 25 4 04.639.730 30 4 04.639.735 35 4 04.639.740 40 6 04.639.745 45 8 04.639.750 50 8 04.639.755 55 6 04.639.760 60 4 04.639.765 65 4 8.0 mm Titanium MATRIX Screws Thread Length (mm) Qty. 04.639.835 35 2 04.639.840 40 4 04.639.845 45 4 04.639.850 50 4 04.639.855 55 2 6.0 mm Titanium MATRIX Screws Thread Length (mm) Qty. 04.639.620 20 4 04.639.625 25 4 04.639.630 30 6 04.639.635 35 8 04.639.640 40 8 04.639.645 45 8 04.639.650 50 6 04.639.655 55 4 04.639.660 60 4 04.639.665 65 4 44 Synthes MATRIX Spine System Degenerative Technique Guide

MATRIX Degenerative Instrument and Titanium Implant Set (01.632.004) 01.632.004 consists of: 01.632.027 MATRIX Instrument Set for Screw Placement 01.632.028 MATRIX Instrument Set for Rod Reduction 01.632.029 MATRIX Instrument Set for Pedicle Preparation 01.632.030 MATRIX Instrument and Titanium Implant Set 01.632.033 MATRIX Long Instrument Set 01.632.027 consists of: 60.632.027 Graphic Case, for Basic MATRIX Instruments 03.620.061 10 Nm Torque Limiting Ratchet Handle, 6 mm hex coupling 03.632.001 Holding Sleeve, standard, 2 ea. 03.632.002 T25 StarDrive Shaft, standard, 2 ea. 03.632.005 Sport Grip T25 StarDrive Shaft, standard 03.632.007 Polyaxial Head Alignment Tool 03.632.036 Holding Sleeve, long, 2 ea. 03.632.072 T25 StarDrive Shaft, long, 2 ea. 03.632.075 Sport Grip T25 StarDrive Shaft, long 03.632.080 Detachable Handle, 2 ea. 03.632.083 Distractor Tip, 2 ea. 03.632.084 Threaded Distractor Tip, 2 ea. 03.632.085 Detachable Holding Sleeve, 2 ea. 03.632.087 MATRIX Distractor Rack, 2 ea. 03.632.089 Footed Distractor Tip, 2 ea. 03.632.090 Ratchet T-Handle, 6 mm quick coupling, 2 ea. Synthes 45

MATRIX Degenerative Instrument and Titanium Implant Set (01.632.004) 01.632.028 consists of: 60.632.028 Graphic Case, for Auxilliary Basic MATRIX Instruments 03.620.017 Compression Forceps 03.620.018 Distraction Forceps 03.620.091 6 mm Hex Drive Adapter 03.632.006 Rod Pusher Countertorque, standard 03.632.008 MATRIX Threaded Persuader, standard, 2 ea. 03.632.009 MATRIX Simple Persuader, standard 03.632.010 Small MATRIX Rocker Fork 03.632.011 Footed MATRIX Rocker Fork 03.632.049 Countertorque for T25, standard 03.632.081 Rod Holding Forceps, for 5.5 mm rods 03.632.098 Ratchet Palm Grip Handle, 6 mm quick coupling 03.632.169 Rod Pusher, for 5.5 mm/6.0 mm rods 01.632.029 consists of: 60.632.029 Graphic Case, for MATRIX Pedicle Preparation Instruments 03.632.098 Ratchet Palm Grip Handle, 6 mm quick coupling Taps for Dual Core Screws, 6 mm hex coupling 03.632.104 4.0 mm 03.632.105 5.0 mm 03.632.106 6.0 mm 03.632.107 7.0 mm 03.632.108 8.0 mm 03.632.109 9.0 mm 388.536 Pedicle Probe with Palm Handle, for 4.0 mm and 4.2 mm screws 388.545 Straight Ball Tip Probe 388.546 Curved Ball Tip Probe 388.654 Palm Ratchet Handle 388.655 Probe with Palm Handle 388.656 Awl with Palm Handle 388.657 Curved Probe with Palm Handle 46 Synthes MATRIX Spine System Degenerative Technique Guide

01.632.030 consists of: 60.632.030 Graphic Case, for Instruments and Titanium MATRIX Implants 03.611.035 4.0 mm Setscrew Extractor, square coupling, 2 ea. 03.611.059 Extender, 6 mm hex coupling 03.632.025 Reduction Sleeve 03.632.026 Countertorque 03.632.029 Reduction Crown, 2 ea. 03.632.030 Tab Removal Tool 03.632.037 Polyaxial Head Placement Tool, 2 ea. 03.632.045 Head Removal Tool 03.632.046 Reamer 03.632.050 Holding Sleeve, for Snap-On Transconnectors 03.632.052 Locking StarDrive Screwdriver Shaft, T15, short, quick coupling 03.632.053 Transconnector Caliper 03.632.204 3.0 Nm Torque Limiting Handle, 4.5 mm quick coupling 04.632.000 Titanium MATRIX Locking Cap, 20 ea. 04.632.001 Titanium MATRIX Top Loading Polyaxial Head, 20 ea. Titanium Snap-On Transconnectors, 2 ea. 04.633.317 17 mm 22 mm 04.633.321 21 mm 26 mm 04.633.326 26 mm 31 mm 04.633.330 30 mm 33 mm 04.633.333 33 mm 38 mm 04.633.338 38 mm 47 mm 04.633.347 47 mm 62 mm 04.633.364 62 mm 90 mm 04.634.002 Titanium Polyaxial Reduction Head, 6 ea. 388.906 Coated Rod Template, for 5.5 mm rods, 150 mm 5.5 mm Titanium Curved Rods Length (mm) Qty. 04.636.030 30 4 04.636.035 35 4 04.636.040 40 4 04.636.045 45 4 04.636.050 50 4 04.636.055 55 4 04.636.060 60 4 04.636.065 65 4 04.636.070 70 4 04.636.075 75 2 04.636.080 80 2 04.636.085 85 2 04.636.125 125 2 Synthes 47

MATRIX Degenerative Instrument and Titanium Implant Set (01.632.004) 01.632.033 consists of: 60.632.033 Graphic Case, for Auxilliary Long Basic MATRIX Instruments 03.632.076 Rod Pusher Countertorque, long 03.632.078 MATRIX Threaded Persuader, long, 2 ea. 03.632.079 MATRIX Simple Persuader, long 03.632.088 Palm Handle, fixed 03.632.099 Countertorque for T25, long 48 Synthes MATRIX Spine System Degenerative Technique Guide

Also Available 7.0 mm Titanium MATRIX Polyaxial Screws Thread Length (mm) 04.632.770 70 04.632.775 75 04.632.780 80 04.632.790 90 04.632.799 100 8.0 mm Titanium MATRIX Polyaxial Screws Thread Length (mm) 04.632.870 70 04.632.875 75 04.632.880 80 04.632.890 90 04.632.899 100 9.0 mm Titanium MATRIX Screws Thread Length (mm) 04.639.970 70 04.639.975 75 04.639.980 80 04.639.990 90 04.639.999 100 5.5 mm Precontoured Rods (Co-28Cr-6Mo) Length (mm) Length (mm) 09.636.030 30 09.636.065 65 09.636.035 35 09.636.070 70 09.636.040 40 09.636.075 75 09.636.045 45 09.636.080 80 09.636.050 50 09.636.085 85 09.636.055 55 09.636.125 125 09.636.060 60 9.0 mm Titanium MATRIX Polyaxial Screws Thread Length (mm) 04.632.970 70 04.632.975 75 04.632.980 80 04.632.990 90 04.632.999 100 7.0 mm Titanium MATRIX Screws Thread Length (mm) 04.639.770 70 04.639.775 75 04.639.780 80 04.639.790 90 04.639.799 100 8.0 mm Titanium MATRIX Screws Thread Length (mm) 04.639.870 70 04.639.875 75 04.639.880 80 04.639.890 90 04.639.899 100 Synthes

Synthes Spine 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322 Fax: (610) 251-9056 Synthes (Canada) Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185 www.synthes.com 2010 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