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OsteoStim ® Cervical Allograft Systems Surgical Technique Contents Introduction ................................................ Page 1 Design Features .......................................... Page 2 Instrumentation .......................................... Page 3 Surgical Technique ...................................... Page 4 Closure And Postoperative Care .................. Page 6 Contraindications ........................................ Page 6 Warnings And Precautions .......................... Page 7 Storage And Shelf Life ................................ Page 7 Product Information .................................... Page 8 Further Information ..................................... Page 11 Introduction The OsteoStim Cervical Allograft System is a line Instrumentation of precision-machined cervical allograft spacers. The OsteoStim Allograft implants offer a unique set of All OsteoStim Cervical Allograft is processed in facilities instrumentation that is simple to use and designed with the accredited by the American Association of Tissue Banks intent of making a direct contribution to successful clinical (AATB) and is cut to exacting standards for exclusive results. The non-reflective finish on each instrument allows distribution by Biomet Spine. for better visualization into the operative site. There are multiple sets of trials and rasps available to accompany both Product Overview the Composite and Cortical Allograft per surgeon preference. They are color-coded and etched with their height in OsteoStim Composite Cervical Allograft millimeters to provide easy identification when determining The OsteoStim Composite Cervical Allograft is composed the appropriate implant size intraoperatively. of cortical bone for strength and dense cancellous bone for ingrowth. The graft, which consists of only two pieces, The orientation of the teeth on the Trial Rasps has been features a single piece of cortical bone to form the anterior designed to cut on the backstroke in order to extract and lateral aspects of the graft, and a dense cancellous dowel cartilaginous material. Trial Rasps may be used for final in the center. The dense cancellous bone is specifically endplate preparation as well as to distract within procured from the load-bearing anatomy, including the vertebral space. the talus, calcaneus and femoral head. Its strength has been tested in undersized disc spaces to withstand repeated The Inserter is designed to mimic the anterior aspect impaction forces. The footprint of the composite graft of the implant. Tines on the Inserter have a directional texture measures 14mm wide with a depth of 13mm. enabling them to engage the implant during insertion and can be used as a remover if necessary. The handle enables OsteoStim Cortical Cervical Allograft impaction of implant with a mallet. The original OsteoStim Cortical Allograft is composed of a single piece of cortical bone and features a 3.5mm core hole In addition to the Inserter, the Tamp permits controlled to pack with bone material if desired. The cortical graft’s positioning of the OsteoStim Allograft implant in the disc footprint measures 14mm wide with a depth of 10mm. space. The Tamp is designed to match the anterior curvature of the implant in order to decrease contact pressure during The available heights of both implants range from 5mm insertion. The handle also facilitates gentle impaction to 12mm in 1mm increments. Both spacers feature 9° with a mallet. of lordosis to closely approximate the curvature of the cervical spine. In addition, each graft is machined with horizontal arcs The Single Sided Rasp may be used in place of or in addition to provide multi-directional expulsion resistance. to the Trial Rasp to extract additional amounts of cartilaginous materials necessary to prepare the endplate for insertion of the implant. 1 Design Features OsteoStim Composite Allograft Both Implants Feature Machined Ridges • Aggressive teeth-like ridges minimize expulsion AATB Accredited • All tissue is procured from an AATB accredited tissue bank Solid Anterior Cortex Two-Piece Construction • Evenly distributes forces during impaction • Maximizes structural stability Lordotic Endplates • Outer cortical portion allows for strength as the inner cancellous portion allows for ingrowth • 9° of lordosis approximates the curvature of the cervical spine • Porous composition of cancellous bone allows for rapid absorption of blood into the implant Supplied Freeze-Dried • 5mm-12mm heights • Conserves valuable hospital resources OsteoStim Cortical Allograft Streamlined Instrumentation • Available with or without stops • Available in shorter lengths for working under a microscope 100% Cortical Bone • Single-Piece Construction maximizes structural stability • Full Range of Sizes • 5mm-12mm heights 2 Instrumentation Lordotic Trial Inserter Lordotic Rasp Trial Tamp Single Sided Rasp 3 Surgical Technique 1. Distraction 3. End Plate Preparation The patient is placed in the supine position on the operative Rasps Trials may be used for further endplate preparation as table with a folded towel beneath the intrascapular region to well as to distract within the vertebral space. This allows for maintain the head in slight extension. The use of a head halter removal of small irregularities along the endplate, ensuring a attached to an outrigger for traction may be helpful. If smooth surface for implant insertion. (Figure 1) fluoroscopy is used, it may be utilized at this point to confirm positioning and visualize the desired vertebral levels. A standard anterior approach to the cervical spine is utilized. This can be through one of several incisions with the exposure medial to the carotid sheath and lateral to the trachea and esophagus. Adequate fascial plane release is important for optimal exposure. After identification of the disc space is confirmed with x-ray, preparation of the site is commenced. (Figure 1) 2. Disc Space Preparation 4. Trialing A discectomy should be performed. Osteophytes at the After the endplates are prepared, Trials are used to determine operative levels may be resected at the surgeon’s discretion. the appropriate size of the implant to be inserted. Trials also All cartilaginous material should be removed and bleeding provide the surgeon with tactile feedback as it relates to the subchondral bone should be exposed. An intact endplate distraction of the vertebral space. (Figure 2) allows for distraction of the interspace while minimizing the possibility of a subchondral fracture and subsidence. (Figure 2) 4 5. Bone Graft Placement Rehydrate the graft for as long as possible in normal saline or the patient’s blood prior to insertion. NOTE: The core of the Cortical Allograft implant may be packed with autogenous bone material at this time. 6. Implant Insertion (Figure 3) Load the graft onto the Inserter by placing it between the tines and manipulating the instrument to fully engage the implant. (Figure 3) Introduce the implant into the vertebral disc space using the Inserter. The implant should be the same height or slightly larger than the size determined by the Trial and should be seated securely within the disc space. (Figure 4) Tap the distal tip of the Inserter with a mallet to gently seat the Repeat steps to insert additional OsteoStim Cervical Allograft implant. The implant may be inserted flush with the anterior Spacer System Implants. rim of the adjacent vertebral bodies or may be countersunk past the anterior rim at the physician’s discretion. Final positioning of all implant(s) should be confirmed using fluoroscopy. Additional autogenous bone material may be Disengage the Implant from the Inserter and remove the placed beside the implants at the surgeon’s discretion. instrument. The Tamp may be utilized to further advance the implant in the disc space. Carefully inspect the interbody Proceed with the application of anterior cervical fusion bed. (Figure 4) instrumentation and closure. 5 Closure And Postoperative Care Contraindications • The operative site should be closed per hospital protocol and the surgeon’s discretion 1. Infection at the surgical site and/or distant foci of infections • Prior to adequate fusion, the physician may prescribe additional external support to accommodate full load bearing • The patient should receive adequate instruction regarding the appropriate post-operative activity levels • The patient should be instructed to report unusual changes at the operative site and the physician should closely monitor the patient if the unusual changes are reported that may spread to the surgical site. 2. Uncooperative patient, or patient with neurologic disorders who is incapable of following directions, including weight control and activity levels. 3. Pregnancy. 4. Disorders or diseases that may impair bone formation. 6 Warnings And Precautions Storage And Shelf Life • This product contains donated human tissue Maintain product at ambient temperature (59°-86°F or • This tissue was processed using some or all of the following agents: Bacitracin (50 u/ml), Polymyxin B Sulfate (500 u/ml), Allowash™, Alcohol and/or Hydrogen Peroxide. Although the tissue was rinsed with sterile water or sterile saline throughout the processing procedure, traces of the medications and chemicals may remain 15°-30°C). No refrigeration is necessary. See package label for expiration date. It is the responsibility of the Tissue Dispensing Service and/or end-user to maintain this product in the appropriate storage conditions prior to transplant. Allowash is a trademark of LifeNet, Inc. • Although this product has been tested and screened for selected human pathogens, processed under aseptic conditions, human derived tissue may still transmit infectious agents • Do not use product if package integrity has been compromised • This product is intended for use in one patient on a single occasion only • Once user breaks the container seal, the product must be transplanted or discarded • This product may not be sterilized or re-sterilized • The patient is to be made aware of general risks associated with treatment and the possible adverse effects 7 Product Information OsteoStim Composite Cervical Allograft Implants (Cat #80112) Universal Lordotic Instruments No Stops (Cat #14-531220) Catalog # Description Catalog # Description 45-5555 5mm Composite Allograft Cervical Spacer 55001914 14mm Inserter 45-5556 6mm Composite Allograft Cervical Spacer 55002198 11mm Tamp 45-5557 7mm Composite Allograft Cervical Spacer 55002195 Single Sided Rasp 45-5558 8mm Composite Allograft Cervical Spacer 55002115 5mm Lordotic Trial 45-5559 9mm Composite Allograft Cervical Spacer 55002116 6mm Lordotic Trial 45-5560 10mm Composite Allograft Cervical Spacer 55002117 7mm Lordotic Trial 45-5561 11mm Composite Allograft Cervical Spacer 55002118 8mm Lordotic Trial 45-5562* 12mm Composite Allograft Cervical Spacer 55002119 9mm Lordotic Trial 55002120 10mm Lordotic Trial 55002121 11mm Lordotic Trial Lordotic Cervical Allograft Implants (Cat #80110) 55002122* 12mm Lordotic Trial Catalog # Description 55002215 5mm Lordotic Rasp 45-5535* 5mm Lordotic Cervical Allograft Spacer 55002216 6mm Lordotic Rasp 45-5536 6mm Lordotic Cervical Allograft Spacer 55002217 7mm Lordotic Rasp 45-5537 7mm Lordotic Cervical Allograft Spacer 55002218 8mm Lordotic Rasp 45-5538 8mm Lordotic Cervical Allograft Spacer 55002219 9mm Lordotic Rasp 45-5539 9mm Lordotic Cervical Allograft Spacer 55002120 10mm Lordotic Rasp 45-5540 10mm Lordotic Cervical Allograft Spacer 55002221 11mm Lordotic Rasp 45-5541* 11mm Lordotic Cervical Allograft Spacer 55002222* 12mm Lordotic Rasp 45-5542* 12mm Lordotic Cervical Allograft Spacer * Special order items, not in standard kit. 8 Short Lordotic Cervical Instruments With Stops (Cat #80115) Lordotic Cervical Instruments No Stops (Cat #80195) Catalog # Description Catalog # Description 05553 Rasp 05502 Rasp 05554 Tamp 05503 Mallet 05555 Inserter 05534 Tamp 05556 6mm Trial 05535 Inserter 05557 7mm Trial 05583* 5mm Trial 05558 8mm Trial 05576 6mm Trial 05559 9mm Trial 05577 7mm Trial 05560 10mm Trial 05578 8mm Trial 05561 11mm Trial 05579 9mm Trial 05562 12mm Trial 05580 10mm Trial 05565* 5mm Rasp 05581* 11mm Trial 05566 6mm Rasp 05582* 12mm Trial 05567 7mm Rasp 05586 6mm Rasp 05568 8mm Rasp 05587 7mm Rasp 05569 9mm Rasp 05588 8mm Rasp 05570 10mm Rasp 05589 9mm Rasp 05571 11mm Rasp 05590 10mm Rasp 05572 12mm Rasp 05591* 11mm Rasp 05503 Mallet 05592* 12mm Rasp * Special order items, not in standard kit. 9 Product Information (Continued) Lordotic Cervical Instruments With Stops (Cat #80120) Catalog # Description 05502 Rasp 05503 Mallet 05534 Tamp 05535 Inserter 05536 6mm Trial 05537 7mm Trial 05538 8mm Trial 05539 9mm Trial 05540 10mm Trial 05541* 11mm Trial 05542* 12mm Trial 05546 6mm Rasp 05547 7mm Rasp 05548 8mm Rasp 05549 9mm Rasp 05550 10mm Rasp * Special order items, not in standard kit. 10 Further Information Please refer to the OsteoStim Cervical Allograft System For further information, please contact the Customer Service package insert for complete indication and labeling limitations. Department at: CAUTION: Federal Law (USA) restricts this device to sale by or Biomet Spine on the order of a physician. 100 Interpace Parkway Parsippany, NJ 07054 The OsteoStim Cervical Allograft Surgical Technique is (973) 299-9300 - (800) 526-2579 presented to demonstrate the surgical technique utilized www.biometspine.com by R. David Bauer, M.D. Biomet Spine, as the manufacturer of this device, does not practice medicine and does not recommend this product or any specific surgical technique for use on any individual patient. The surgeon who performs any implant procedure is responsible for determining the appropriate product(s) and utilizing the appropriate technique(s) for said implantation in each individual patient. 11 Notes: 12 100 Interpace Parkway Parsippany, NJ 07054 www.biometspine.com 800-526-2579 All trademarks are the property of Biomet, Inc., or one of its subsidiaries, unless otherwise indicated. Rx Only. Copyright 2008 Biomet, Inc. All rights reserved. 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