Navigation Array Kit for Brainlab®

Disclaimer: This document is intended exclusively for physicians and is not intended for laypersons. Distribution to any other recipient is prohibited. Information on the products and procedures contained in this document is of a general nature and does not represent and does not constitute medical advice or recommendations. Because this information does not purport to constitute any diagnostic or therapeutic statement with regard to any individual medical case, each patient must be examined and advised individually, and this document does not replace the need for such examination and/or advice in whole or in part. 

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Rx only. Please refer to the package inserts for important product information, including, but not limited to, indications, contraindications, warnings, precautions, adverse effects, and patient counseling information.

eLabeling: The Instructions for Use can be accessed online by visiting the website shown below. Additional languages are also available in electronic format for download. To request a paper copy of the Instructions for Use, contact ZimVie Spine at the phone number provided.

Consult Instructions for Use on this website http://labeling.zimvie.com 

Unless otherwise indicated, as referenced herein, all trademarks and intellectual property rights are the property of ZimVie Inc. or an affiliate; and all products are manufactured by one or more of the spinal subsidiaries of ZimVie Inc. (Zimmer Biomet Spine, Inc., Zimmer Spine, LDR Medical, etc.) and marketed and distributed by Zimmer Biomet Spine and its authorized marketing partners. Medtronic StealthStation, Medtronic Synergy Experience and Medtronic are trademarks of Medtronic PLC. Vital Navigation System is manufactured by Zimmer Biomet Spine. For additional product information, please refer to the individual product labeling or instructions for use. Products within this system are under the design control of various legal manufacturers. Refer to the product labeling of each device for the legal manufacturer. Product clearance and availability may be limited to certain countries/regions. This material is intended for clinicians only and does not comprise medical advice or recommendations. Distribution to any other recipient is prohibited. This material may not be copied or reprinted without the express written consent of ZimVie.  ZVINST0180.1-US-EN-2023.12 ©2023 ZimVie Inc. All rights reserved. 

WARNINGS AND PRECAUTIONS

Following are specific warnings, precautions, and adverse effects associated with use of the Vital Navigation System that should be understood by the surgeon and explained to the patients. Surgeons should be thoroughly familiar with these instructions, in addition to all other product labeling. General surgical risk should be explained to the patients prior to surgery.

• Implantation of the Vitality System should be performed only by experienced spinal surgeons.
• All implants are intended for single use only. Single use devices should not be re-used. Possible risks associated with re-use of single-use devices include:

- Mechanical malfunction

- Transmission of infectious agents

• Metal sensitivity has been reported following exposure to orthopedic implants. The most common metallic sensitivities (nickel, cobalt, and chromium) are present in medical grade stainless steel and cobalt-chrome alloys.
• Universal precautions should be observed by all end users that work with contaminated or potentially contaminated medical devices. Caution should be exercised when handling devices with sharp points or cutting edges to prevent injuries during and after surgical procedures and reprocessing.
• ZimVie does not warrant Medtronic or Brainlab Navigation Software. It is the sole responsibility of the user to ensure instrument calibration and/or registration.
• The Use of the Vital Navigation System should only be used with the indicated Vital and Vitality screw systems.
• Users must complete verification steps as required per the Medtronic or Brainlab Navigation Technique.
• Users must ensure that surgical accuracy be assessed before the procedure and repeatedly throughout the procedure by positioning the tip of each navigated instrument on an identifiable anatomical landmark and comparing the actual tip location to that displayed by the system. When verifying the accuracy of the Navigated Drivers, the accuracy test must include the screw (of which diameter and length are selected/entered into the software) assembled securely onto the driver.  The screw tip will be placed on an identifiable anatomical landmark and compared to the tip location as displayed on the screen.
• In the event of a registration failure or suspected inaccuracy, the Navigated Instruments should not be used with the Navigation System and the instruments should be inspected for damage before continuing with the traditional, non-navigated procedure.
• The Vital Navigation System instruments should not be bent or altered in any way as this could lead to a reduction in system accuracy.
• Warning: The safety and effectiveness of pedicle screw spinal 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 conditions are unknown.
• Warning: The safety and effectiveness of this device has not been established for use as part of a growing rod construct. The device is only intended to be used when definitive fusion is being performed at all instrumented levels.

• 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 malpositioning 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.
• Precaution: 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.
• 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.
• Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and placement of the implants are important considerations in the successful utilization of the system in pediatric patients.
• The selection of the proper size, shape and design of the implant for each patient is crucial to the safe use of this device in pediatric patients.