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OPERATIVE TECHNIQUE JANUS® MIDLINE FIXATION SCREW FIREBIRD® SPINAL FIXATION SYSTEM phoenix® minimally invasive spinal fixation system TA BL E OF CON T E N T S Introduction3 Operative Technique 4 Instruments19 Implants20 Indications for Use 21 The surgical technique shown is for illustrative purposes only. The technique(s) actually employed in each case will always depend upon the medical judgment of the surgeon exercised before and during surgery as to the best mode of treatment for each patient. Please see Instructions for Use for the complete list of indications, warnings, precautions, and other important medical information. INTRODUCTION INTRODUCTION As an addition to the Firebird® Spinal Fixation System, the JANUS® Midline Fixation Screw from Orthofix provides surgeons with the option of a midline approach. The JANUS Midline Fixation Screw is designed to achieve more cortical bone purchase in the medial to lateral trajectory when compared to traditional pedicle screws. With its modular screw design, maximized visualization is possible when working in a smaller midline incision or minimally invasive surgical approach. JANUS Midline Fixation Screw is available in both non-cannulated and cannulated versions. Non-Cannulated Cannulated 3 4 OPERATIVE TECHNIQUE Fig. 1 Fig. 2 1. ACCESS 2. IDENTIFICATION OF ENTRY POINT A posterior midline incision is made followed by a standard posterior midline approach and placement of common retractors to maintain exposure. The approach is extended to identify the lateral border of the facet and the lateral edge of the pars. In cephalad caudal direction the exposure is to the mid facet for the cephalad level and to the mid-lamina for the caudal level. (Fig. 1) Proper entry point for the JANUS Midline Fixation Screw is at the inferior border of the transverse process and about 3mm to 5mm medial to the lateral edge of the pars (approximately the midpoint of the inferior facet of the level above). This position allows the starting point to be superior to the neuroforamen. Obtain an AP image to confirm the entry point is the medial border of the pedicle at a 7 o’clock position for the right pedicle, and a 5 o’clock position for the left pedicle. (Fig. 2) NOTE: When using the JANUS cannulated screw in an MIS procedure, refer to to the Phoenix Minimally Invasive Spinal Fixation System Operative Technique. Fig. 2 OPERATIVE TECHNIQUE Fig. 3a Fig. 3b TRAJECTORY FOR CORTICAL CANCELLOUS SCREW PLACEMENT 3. SCREW STARTING POINTS Move the C-arm to a lateral position, aim and advance the bone probe to the posterior 1/3 or mid portion of the superior endplate, while aiming approximately 15-20 degrees medial to lateral. The result is an acute trajectory above the neuroforamen and positioned away from the central canal and the exiting nerve root. Note that the sagittal plane inclination of the probe should be at the greatest angle in the caudal-to-cephalad direction. Use modular screws for the midline approach indicated by the red lines. (Figs. 3a and 3b) 5 6 OPERATIVE TECHNIQUE Fig. 4 Fig. 5 4. BONE AWL 5. BONE PROBE (52-1001) Penetrate the cortex of the bone with the bone awl to create a pilot hole at the entry point. (Fig. 4) (52-1002 / 52-1003) Aim for the posterior 1/3 or mid portion of the superior endplate in the sagittal plane, while aiming approximately 15-20 degrees medial to lateral. (Fig. 5 ) OPERATIVE TECHNIQUE Fig. 6 Fig. 7 6. DRILLING 7. SOUNDER (36-1124 / 36-1125 / 36-1126 / 36-1127) (52-1004 Small / 52-1005 Large) Use the sounder to confirm the existence of bone along the walls of the screw trajectory. Choose the appropriate tip and internally palpate to ensure the walls are not perforated. (Fig. 7) Use the drill that corresponds to the selected bone screw diameter. The proximal end of the drill shaft has a colored band that corresponds to the diameter of the screw. Use the A/O quick connect feature on the drill to connect the Modular Handle (69-1030). Insert the drill into the Drill Guide (36-1012). Prior to start of drilling, ensure that the tip of the Drill is in the pilot hole created by the Awl. The drill should be advanced slowly and controlled while using irrigation to prevent bone injury. Aim for the posterior 1/3 or mid portion of the superior endplate in the sagittal plane, while aiming approximately 15-20 degrees medial to lateral. The endplate should not be breached. The drill is capable of drilling 28.5mm deep holes. (Fig. 6) Diameter Screw Color Drill Color Tap Color 4.5mm Silver Silver Silver 5.5mm Green Green Green 6.5mm Gold Gold Gold 7.5mm Blue Blue Blue 7 8 OPERATIVE TECHNIQUE Fig. 8 Fig. 9 8. X-RAY MARKERS 9. SCREW SIZING TEMPLATE (55-1006 Right / 52-1007 Left) Use the right and left x-ray markers to confirm trajectory under fluoroscopy prior to screw insertion. (Fig. 8) Use the Screw Sizing Template (52-1308) to verify screw diameter and length of the JANUS Midline Fixation Screw prior to insertion. (Fig. 9) OPERATIVE TECHNIQUE Fig. 10 10. TAP Tap the pilot hole with the same size bone tap as the final screw diameter and advance to the superior endplate. Tap to the appropriate depth based on the length of the JANUS Midline Fixation Screw to be implanted for optimal screw purchase, using the 5 millimeter increment markings on the tap as a guide. Do not violate the endplate. Select the Bone Tap (36-XXXX) that matches the bone screw diameter that will be used. The Bone Tap dimensions are line to line (one to one) with the bone screw dimensions. The bone tap only includes the bone screw cancellous thread form. Use Bone Tap (36-) to tap the pilot hole and continue advancing the bone tap to endplate of the vertebral body. Use the 5mm markings along the length of the bone tap shaft to determine how deep the tip of the bone tap is advancing. (Fig. 10) NOTE: Tapping is required prior to inserting a JANUS Midline Fixation Screw, the optional JANUS Cortical Bone Tap (36-XXXX) must be used. Firebird and Phoenix® Taps are designed with a different thread pitch. To reduce the risk of screw pullout, it is not recommended to use a Firebird or Phoenix Tap to prepare the hole for a JANUS Midline Fixation Screw insertion. NOTE: To attach the Ratcheting Handle, T-Handle 52-1011) or Ratcheting Handle Straight, Small (52-1013) to the modular taps, retract the shaft connector sleeve and insert the square-drive shaft end of tap into the handle connector, and release shaft connector sleeve. To disengage the tap from the handle, retract the shaft connector sleeve and firmly tug on the instrument shaft. NOTE: Ensure that the Tap is fully inserted and seated inside the Straight or Ratcheting T-handle, prior to the application of torque. Inadequate seating may create a binding condition with the handle, after torque is applied. Proper connection of the shaft with the handle can be confirmed by gently tugging on the shaft 9 10 OPERATIVE TECHNIQUE Fig. 11 11. SCREW INSERTION Midline Screw Driver (36-1834) Insert the self-retaining driver completely into the JANUS screw. Insert the JANUS screw until it is positioned at the posterior 1/3 or mid portion of the superior endplate. The screw should not perforate the endplate. The spherical screw head should be left slightly proud to avoid damage to the facet joint. To disengage the Midline Screw driver, lift the screw driver until it separates from the JANUS screw. NOTE: Do not apply levering force to driver during screw insertion as this can result in missed trajectory of screw or vertebral fractures. NOTE: If the screw insertion site is not prepared by drilling and tapping, there is an increased chance of toggle between the bone screw and the Modular Screw Driver (36-1834) that could affect bone screw trajectory. Fig. 12 12. DECORTICATION Decorticating Planer (52-1334) After placement of the modular JANUS Midline Fixation Screw, place the decorticating planer over the spherical head of the bone screw. Rotate the planer surface clockwise and counterclockwise to decorticate bone and allow for proper seating of modular body providing full range of motion. (Fig. 12) OPERATIVE TECHNIQUE Fig. 13 Fig. 14 13. SCREW BODY OPTIONS 14. MODULAR BODY ATTACHMENT Top-Loading (44-2101) Insert the rod from a top orientation prior to securing with set screw. After placement of the modular JANUS Midline Fixation Screw, attach the appropriate modular body to the Holder (51-7100) by aligning the pin holes on body with inserter and clamp. Slide the body onto the bone screw by applying an axial force to connect the base of the body to the spherical head of the JANUS Midline Fixation Screw. The pressure cap will move freely in the body to allow for proper insertion. Reduction (44-2103) Insert the rod from a top orientation prior to securing with set screw. Break off tabs after set screw is below the line of the extended tabs. (Fig. 13) Confirm a secure connection between the body and bone screw by pulling up on the holder prior to disconnecting. When the body remains attached to the bone screw, the assembly is secure. (Fig. 14) 11 12 OPERATIVE TECHNIQUE Fig. 15 Fig. 16 15. BODY ALIGNMENT 16. ADJUSTMENT DRIVER Head Adjuster (52-1038) Use the head adjuster to align the top opening bodies of the multi-axial screw prior to rod insertion. Multi-Axial Adjustment Driver (52-1339) Use the multi-axial adjustment driver to adjust the sagittal height of the screws prior to rod insertion. (Fig. 16) NOTE: This instrument can assist in restoring mobility of the multi-axial bodies if screw has been driven too deep. (Fig. 16) OPERATIVE TECHNIQUE Fig. 17 Fig. 18 17. ROD PREPARATION 18. ROD CUTTING Rod Template Pin Cutter (55-1041) Once the correct length is established, use the rod cutter to cut rod to the desired length referencing the rod template as a guide. (Fig. 18) Determine the rod contour and length required using the trial rod (52-1040 thru 52-1042). Rod Selection NOTE: When there is need for a stiffer rod, Cobalt Chrome rods may be used as an alternative to Titanium rods. NOTE: Both rod materials are compatible with standard Titanium Firebird Spinal Fixation System implants. (Fig. 17) 13 14 OPERATIVE TECHNIQUE Fig. 19 Fig. 20 19. ROD CONTOURING 20. ROD INSERTION Rod Bender (52-1046) Utilizing the rod bender, create the correct contour, referencing the rod template as a guide. See step 17 for determining rod length. Rod Inserter (52-1581) Orient the screws so that the screw bodies are in the longitudinal plane. Once positioning is achieved, use the rod inserter to place the rod in the screw bodies. WARNING: The rods should not be repeatedly or excessively bent any more than absolutely necessary. The rods should not be reverse bent in the same location. (Fig. 19) NOTE: Avoid applying unnecessary lateral bending or rotational force to rod inserter. NOTE: Ensure the rod seating area is clear of any bony/tissue interferences before attempting to reduce the rod. (Fig. 20) OPERATIVE TECHNIQUE Fig. 21 Fig. 22a 21. ROD ROCKER 22A. ROD PUSHER Rod Rocker (52-1251) Attach rocker to screw body and lever rod until seated in the screw. Rod Pusher (52-1050) Position rod pusher tip on rod and apply axial force until rod is seated in screw NOTE: Unnecessary lateral bending or excess rotational force may cause reducer to slip from screw head during reduction or the inability to properly insert set screw. NOTE: Applying too much reduction force to screws can result in screw pullout. (Fig. 21) body. (Fig. 22a) 15 16 OPERATIVE TECHNIQUE Fig. 22b Fig. 23 22B. ROD REDUCER 23. FINAL TIGHTENING Rod Reducer (52-1755) Slide rod reducer tip over the screw body and seat pins into indents. Take care to align inner shaft with rod prior to reduction. (Fig. 22b) Counter Torque Wrench (52-1765) Set Screw Driver (52-1061) Torque Limiting Handle (52-1512) Position the counter torque wrench over the screw and rod making sure to engage tips to align rod within screw body. Place the set screw driver through the cannulation of the counter torque wrench and into the hex of the set screw. Turn the torque limiting handle clockwise and apply counter torque with the counter torque wrench to tighten the set screw to 100 in-lbs. The torque limiting handle will reach its maximum torque and release at 100 in-lbs. NOTE: Insert the set screw driver into the torque limiting handle by compressing connection mechanism. Ratcheting feature will not function properly unless driver is fully seated before releasing connection mechanism. Ensure the ratcheting dial is set to forward “F” prior to engaging the set screw. (Fig. 23) OPERATIVE TECHNIQUE Fig. 24 24. REMOVAL Set Screw Driver (52-1061) Counter Torque Wrench (52-1765) Multi-Axial Adjustment Driver (52-1339) In order to remove the JANUS Midline Fixation Screw, fully seat the set screw driver securely into the set screw and turn counter clockwise to loosen the set screw. Use of counter torque wrench is recommended to avoid damage to the pedicle. Carefully remove all set screws. The multi-axial adjustment driver can be utilized to remove the screw assemblies. The multi-axial adjustment driver must be used to remove bone screws that are attached to offset heads. (Fig. 24) 17 18 INSTRUMENTS AND IMPLANTS Instruments and Implants IMPORTANT ORDERING INFORMATION: the instrument case and JANUS screw caddies have individual product numbers and must be ordered at the same time. The JANUS cannulated and non-cannulated screw caddies are not included in the instrument case during shipment. The JANUS screw caddies should be placed inside the instrument case for the procedure, cleaning and sterilzation. INSTRUMENTS INSTRUMENTS Drills Part # Description 36-11244.5mm 36-11255.5mm 36-11266.5mm 36-11277.5mm Non-cannulated Cortical Bone Tap, Modular) Part # Description 36-12244.5mm 36-12255.5mm 36-12266.5mm 36-12277.5mm Cannulated Cortical Bone Tap, Modular) Part # Description 36-14244.5mm 36-14255.5mm 36-14266.5mm 36-14277.5mm Handle) Part # Description 69-1030 Modular Handle Part # Description 36-1012 Drill Guide 36-1834 Midline Screw Driver Drill Guide Handle ) 36-7200Instruments Top Level Bottom Level 19 20 IMPLANTS IMPLANTS 36-9100 Non-Cannulated Implant Caddy Part # Description 36-2425 36-2430 36-2435 36-2440 36-2445 36-2525 36-2530 36-2535 36-2540 36-2545 36-2625 36-2630 36-2635 36-2640 36-2645 4.5mm x 25mm 4.5mm x 30mm 4.5mm x 35mm 4.5mm x 40mm 4.5mm x 45mm 5.5mm x 25mm 5.5mm x 30mm 5.5mm x 35mm 5.5mm x 40mm 5.5mm x 45mm 6.5mm x 25mm 6.5mm x 30mm 6.5mm x 35mm 6.5mm x 40mm 6.5mm x 45mm Qty Availability 6 6 6 6 6 6 6 6 6 6 4 4 4 4 4 Standard Standard Standard Standard Standard Standard Standard Standard Standard Standard Standard Standard Standard Standard Standard 36-9200 Cannulated Implant Caddy Part # 36-3425 36-3430 36-3435 36-3440 36-3445 36-3525 36-3530 36-3535 36-3540 36-3545 36-3625 36-3630 36-3635 36-3640 36-3645 Description 4.5mm x 25mm 4.5mm x 30mm 4.5mm x 35mm 4.5mm x 40mm 4.5mm x 45mm 5.5mm x 25mm 5.5mm x 30mm 5.5mm x 35mm 5.5mm x 40mm 5.5mm x 45mm 6.5mm x 25mm 6.5mm x 30mm 6.5mm x 35mm 6.5mm x 40mm 6.5mm x 45mm Qty Availability 6 Standard 6 Standard 6 Standard 6 Standard 6 Standard 6 Standard 6 Standard 6 Standard 6 Standard 6 Standard 4 Standard 4 Standard 4 Standard 4 Standard 4 Standard Optional Non-Cannulated Implants Part # 36-2450 36-2455 36-2460 36-2465 36-2550 36-2555 36-2560 36-2565 36-2650 36-2655 36-2660 36-2665 36-2725 36-2730 36-2735 36-2740 36-2745 36-2750 36-2755 36-2760 36-2765 Description 4.5mm x 50mm 4.5mm x 55mm 4.5mm x 60mm 4.5mm x 65mm 5.5mm x 50mm 5.5mm x 55mm 5.5mm x 60mm 5.5mm x 65mm 6.5mm x 50mm 6.5mm x 55mm 6.5mm x 60mm 6.5mm x 65mm 7.5mm x 25mm 7.5mm x 30mm 7.5mm x 35mm 7.5mm x 40mm 7.5mm x 45mm 7.5mm x 50mm 7.5mm x 55mm 7.5mm x 60mm 7.5mm x 65mm Availability By request By request By request By request By request By request By request By request By request By request By request By request By request By request By request By request By request By request By request By request By request Optional Cannulated Implants Part # 36-3450 36-3455 36-3460 36-3465 36-3550 36-3555 36-3560 36-3565 36-3650 36-3655 36-3660 36-3665 36-3725 36-3730 36-3735 36-3740 36-3745 36-3750 36-3755 36-3760 36-3765 Description 4.5mm x 50mm 4.5mm x 55mm 4.5mm x 60mm 4.5mm x 65mm 5.5mm x 50mm 5.5mm x 55mm 5.5mm x 60mm 5.5mm x 65mm 6.5mm x 50mm 6.5mm x 55mm 6.5mm x 60mm 6.5mm x 65mm 7.5mm x 25mm 7.5mm x 30mm 7.5mm x 35mm 7.5mm x 40mm 7.5mm x 45mm 7.5mm x 50mm 7.5mm x 55mm 7.5mm x 60mm 7.5mm x 65mm Availability By request By request By request By request By request By request By request By request By request By request By request By request By request By request By request By request By request By request By request By request By request INDICATIONS FOR USE Description: The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are temporary, multiple component systems comprised of a variety of non-sterile and sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The systems are attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System consist of an assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, hooks, iliac connectors and STERILE packed HA Coated bone screws. A subset of the Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System components may be used in pediatric patients. These components consist of a variety of screws ranging in diameters from 4.0mm to 7.5mm and lengths ranging from 25mm to 60mm. The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System implants are not compatible with components or metal from any other manufacturer’s system. Indications for Use: The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for all of the following indications: a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) b) spondylolisthesis, c) trauma (i.e., fracture or dislocation), d) spinal stenosis, e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), f) tumor, g) pseudoarthrosis, and h) failed previous fusion When used for fixation to the ilium, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws planced at the S1 or S2 spinal level. The Phoenix MIS Spinal Fixation System when used with the Firebird Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery. The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Firebird Spinal Fixation System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Contraindications include, but are not limited to: 1. Morbid obesity 2. Mental Illness 3. Alcoholism or drug abuse 4. Pregnancy 5. Metal sensitivity/allergies 6. Severe osteopenia 7. Patients unwilling or unable to follow post-operative care instructions 8. Use of the Firebird offset connectors for fixation to the ilium is contraindicated when the sacrum is absent or insufficient for implantation of pedicle screws at the S1 or S2 spinal level. 9. Any circumstances not listed under the heading indications. Potential Adverse Events: All of the possible adverse events associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a listing of possible adverse events includes, but is not limited to: 1. Inability to use pedicle screw fixation due to anatomic limitations (pedicle dimensions, distorted anatomy) 2. Pedicle screw mal positioning, with or without neurological or vascular injury 3. Proximal or distal junctional kyphosis 4. Pancreatitis 5. Pedicle screw fixation, such as screw or rod bending, breakage, or loosening, may also occur in pediatric patients, and pediatric patients, and pediatric patients may be at increased risk for device-related injury because of their smaller stature. 6. Device component fracture 7. Loss of fixation 8. Non-union 9. Fracture of the vertebra 10. Neurological injury 11. Vascular or visceral injury 12. Early or late loosening of any or all of the components 13. Disassembly and/or bending of any or all components 14 Foreign body (allergic) reaction to implants, debris, corrosion products, graft material, including metallosis, straining, tumor formation, and/or auto-immune disease 15. Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing skin penetration, irritation, and/or pain 16. Post-operative change in spinal curvature, loss of correction, height, and/or reduction 17. Infection 18. Pain, discomfort, or abnormal sensations due to the presence of the device 19. Hemorrhage 20. Cessation of any potential growth of the operated portion of the spine 21. Death Note: Potential risks identified with the use of the device system may require additional surgery. 21 22 INDICATIONS FOR USE Warnings and Precautions: 1. The safety and effectiveness of this device has not been established for use as part of a growing rod construct. This device is only intended to be used when definitive fusion is being performed at all instrumented levels. 2. The use of pedicle screw fixation in the pediatric population may present additional risks when patients are of smaller stature and skeletally immature. Pediatric patients may have smaller spinal structures (pedicle diameter or length) that may preclude the use of pedicle screws or increase the risk of pedicle screw mal positioning and neurological or vascular injury. Patients who are not skeletally mature undergoing spinal fusion procedures may have reduced longitudinal spinal growth, or may be at risk for rotational spinal deformities (the “crankshaft phenomenon”) due to continued differential growth of the anterior spine. 3. The implantation of pedicle screw spinal systems in pediatric patients should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system in pediatric patients because this is a technically demanding procedure presenting a risk of serious injury to the patient. 4. Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection of placement of the implants are important considerations in the successful utilization of the system in pediatric patients. 5. The selection of proper size, shape and design of the implant for each patient is crucial to the safe use of this device in pediatric patients. 6. The safety and effectiveness of pedicle screw systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are: significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). The safety and effectiveness of these devices for any other condition are unknown. 7. Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines. 8. Potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury. 9. Single use only 10. Non-sterile; the screws, hooks, rods, dominos, lateral offsets, spacers, staples, washers, locking nuts, cross connectors, and instruments are sold non-sterile, and therefore must be sterilized before use. 11. To facilitate fusion, a sufficient quantity of autologous bone or other appropriate material should be used. 12. Failure to achieve arthrodesis will result in eventual loosening and failure of the device construct. 13. Excessive torque applied to the screws may strip the threads in the bone. 14. DO NOT REUSE IMPLANTS. Discard used, damaged, or otherwise suspect implants. 15. The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient. 16. Based on fatigue testing results, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. which may impact on the performance of the system. 17. Mixing of dissimilar metals can accelerate the corrosion process. Do not use the titanium alloy or cobalt chrome alloy components of this system with implants of other material composition or components from different manufacturers unless specifically stated. 18. The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System have not been evaluated for safety and compatibility in the MR environment, nor have the Firebird Spinal Fixation System or the Phoenix MIS Spinal Fixation System been tested for heating or migration in the MR environment. 19. Reuse of the devices labeled as single-use could result in injury or re-operation due to breakage or infection. Do not attempt to re-sterilize single-use implants that come in contact with body fluids. 20. When using the offset connectors to connect the Firebird spinal construct to the ilium, pedicle screws must be used at the S1 or S2 level of the spine. Do not use the offset connectors to connect the ilium without this intermediate screw fixation. 21. The safety, efficacy and performance of the system have been established for conditions in which the system is used as intended and when used as identified in the Indications for Use. Performance of the system has not been evaluated for use that is contrary to the Intended Use, Indications for Use or for use that in contraindicated. Failure to use the system as indicated could detrimentally affect the performance of its components. 22. Other adverse effects related to pedicle screw fixation, such as screw or rod bending, breakage, or loosening, may also occur in pediatric patients. Pediatric patients may be at increased risk for device-related injury because of their smaller stature. 23. The correct handling of the implant is extremely important. Implants should not be excessively or repeatedly bent, notched or scratched. These operations can produce defects in surface finish and internal stress concentrations, which may become the focal point for eventual failure of the device. 23 Distributed by: Manufactured by: Orthofix 3451 Plano Parkway Lewisville, Texas 75056-9453 USA 214-937-2000 0086 1.888.298.5700 orthofix.com JA-1607 © Orthofix Holdings, Inc. 10/2016 Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Proper surgical procedure is the responsibility of the medical professional. Operative techniques are furnished as an informative guideline. Each surgeon must evaluate the appropriateness of a technique based on his or her personal medical credentials and experience. Please refer to the “Instructions for Use” supplied with the product for full information on indications for use, contraindications, warnings, precautions, adverse reactions information and sterilization.