Following are specific warnings and precautions associated with use of the Vital Navigation System that should be understood by the surgeon and explained to the patients. General surgical risk should be explained to the patients prior to surgery.

Warnings

• 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 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 Navigation Operative 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.

Additional Warnings for Pediatric Patients:

• 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.

Additional Precautions for Pediatric Patients:

• 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.

PREOPERATIVE

• Usage of automated cleaning processes without supplemental manual cleaning may not result in adequate cleaning of instruments.
• Proper handling, decontamination (including pre-rinsing, washing, rinsing and sterilization), storage and utilization are important for the long and useful life of all surgical instruments. Even with correct use, care and maintenance, they should not be expected to last indefinitely. This is especially true for cutting instruments (e.g., bone awls/drills) and driving instruments (e.g., drivers). These items are often subjected to high loads and/or impact forces. Under such conditions, breakage can occur, particularly when the item is corroded, damaged, nicked or scratched.
• Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct; otherwise, galvanic corrosion may occur.
• Zimmer Biomet does not specify the maximum number of times a re-usable instrument may be re-used. The useful life of these instruments is highly dependent on a number of factors including the frequency and manner in which they are used and the handling they experience in between uses.

INTRAOPERATIVE

• If contouring of the implant is necessary for optimal fit, the contouring should be gradual and avoid any notching or scratching of the implant surface. Do not repeatedly or excessively bend the implant. Do not reverse bend
  the rods.
• Pedicle bone integrity should be verified.
• Care should be taken during pedicle preparation to
  avoid penetrating too deep.
• Care should be taken during bone preparation to avoid damage to the pedicle and to the surgical instruments.
• Care should be taken to minimize soft tissue damage during surgery.
• Care should be taken to avoid removing excess material from the lamina.
• Care should be taken to avoid cross-threading screws and closure tops.
• If any implant or instrument comes in contact with a
  non-sterile surface it should not be used.

POSTOPERATIVE

• Adequately instruct the patient. Postoperative care and the patient’s ability and willingness to follow instructions are one of the most important aspects of successful bone healing. The patient must be made aware of the limitations of the implant and that physical activity and full weight bearing have been implicated in fracture. The patient should understand that an implant is not as strong as normal, healthy bone and will fracture if excessive demands are placed on it in the absence of complete bone healing. An active, debilitated, or demented patient who cannot properly use weight-supporting devices may be particularly at risk during postoperative rehabilitation.
• The Vitality System is a temporary internal fixation device. Internal fixation devices are designed to stabilize the operative site during the normal healing process. After healing occurs, these devices serve no functional purpose and should be removed. Implant removal should be followed by adequate postoperative management to avoid fracture or refracture.

Complications and adverse reactions have been reported with the use of similar spinal instrumentation systems. These adverse effects, including the possibility of death, should be discussed with the patient prior to surgery.

• Non-union, delayed union
• Bending or fracture of implant. Fraying, kinking, loosening, bending or breaking of any or all implant components.
• Loosening of or migration of the implant
• Metal sensitivity or allergic reaction to a foreign body
• Infection
• Decrease in bone density due to stress shielding
• Pain, discomfort, or abnormal sensations due to the presence of the device
• Loss of the natural curvature of the spine
• Modification of the spinal geometric corrections of the vertebral and/or intervertebral height and/or of the reduction in spinal deformities
• Vascular and/or nerve damage due to surgical trauma
  or presence of the device.
• Neurological difficulties including bowel and/or bladder dysfunction, impotence, retrograde ejaculation and paraesthesia.
• Bursitis
• Dural leak
• Paralysis
• Death
• Erosion of blood vessels due to the proximity of the device, leading to hemorrhage and/or death
• Additional surgery may be required to correct any of these potential adverse effects

Additional Potential Adverse Effects for Pediatric Patients:

• Inability to use pedicle screw fixation due to anatomic limitations (pedicle dimensions, distorted anatomy)
• Pedicle screw malpositioning, with or without neurological or vascular injury
• Proximal or distal junctional kyphosis
• Pancreatitis
• Other adverse events related to pedicle screw fixation, such as screw or rod bending, breakage, or loosening, may also occur in pediatric patients, and pediatric patients may be at increased risk for device-related injury because of their smaller stature.