Warnings

Following are specific warnings, precautions, and adverse effects associated with use of the Virage 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.

• Implantation of the Virage 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.
• The Virage 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.
• 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. 
• 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.
• Precaution: The implantation of spinal fixation systems should be performed only by experienced spinal surgeons with specific training in the use of these spinal systems because this is a technically demanding procedure presenting a risk of serious injury to the patient. Preoperative planning and patient anatomy should be considered when selecting implant diameter and length.

Additional preoperative, intraoperative, and postoperative warnings and precautions:

Preoperative

• Pre-op Planning: Use of cross sectional imaging (i.e., CT and/or MRI) for posterior cervical screw placement is recommended due to the unique risks in the cervical spine. The use of planar radiographs alone may not provide the necessary imaging to mitigate the risk of improper screw placement. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.
• 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. See DESCRIPTION section for Virage System materials and compatibility information. 

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 plate or rods.
• Bending the plate outside of the bend zone groove may result in cracking of the plate. Surgeon should always inspect the plate before implanting.
• Occiput and pedicle bone integrity should be verified.
• Care should be taken during occiput and pedicle preparation to avoid penetrating too deep.
• Care should be taken to ensure occipital screw is not driven in 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 some 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 Virage 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.