Warnings
Some metals, polymers, chemicals and other materials used with orthopedic implants have been known to cause cancer and other adverse body reactions, or reports in the literature have suggested such causation. Any factor that causes chronic damage to tissues may be oncogenic. Cancer can metastasize from soft tissue sites (lung, breast, digestive system and others) to bone, including areas adjacent to implants, or it can be seeded to these locations during operative and diagnostic procedures (such as biopsies). Paget disease has been reported to progress to cancer; surgical candidates suffering from this disease should be warned accordingly.
Implantation of foreign material in tissues can elicit an inflammatory reaction. Current literature suggests that wear debris (including metal, polyethylene, ceramic, and cement particles) can initiate the process of histiocytic granuloma formation and consequent osteolysis and loosening. 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.
inViZia Anterior Cervical Plate 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 must be removed. Implant removal should be followed by adequate postoperative management to avoid fracture or refracture.
Precautions
The inViZia Anterior Cervical Plate System instrumentation should only be used after the surgeon has had adequate training in this method of fixation and has become thoroughly knowledgeable about the spinal anatomy and biomechanics. A surgical technique for the inViZia Anterior Cervical Plate System is available upon request. This technique is not a substitute for training and is for general informational purposes only.
The inViZia System uses the Trinica System bone screws and plate bender. Components from other anterior cervical plating systems, however, should not be used with the inViZia System because compatibility has not been established.
Do not use implants made from dissimilar metals (such as cobalt chromium-molybdenum alloy or stainless steel) in contact with components of the inViZia Anterior Cervical Plate System; otherwise, galvanic corrosion may occur.
If contouring of the implant is necessary for optimal fit, the contouring should be gradual and avoid any notching or scratching of the implant(s) surface. The plates must not be repeatedly or excessively bent. Do not reverse bend the plate.
All implants and some instruments are intended for singleuse only; refer to the product label to determine whether the instrument is 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
