Warnings:
Some metals, polymers, chemicals, and other materials utilized 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’s 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.
Trinica and Trinica Select Anterior Cervical Plate Systems are temporary internal fixation devices. 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 Trinica and Trinica Select Anterior Cervical Plate Systems 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 Trinica and Trinica Select Anterior Cervical Plate Systems is available upon request. This technique is not a substitute for training and is for general informational purposes only.
Components from other anterior cervical plating systems must not be intermixed with the Trinica and Trinica Select Anterior Cervical Plate Systems components since compatibility of the components is not known.
Do not use implants made from dissimilar metals (such as cobalt chromium-molybdenum alloy or stainless steel) in contact with components of the Trinica and Trinica Select Anterior Cervical Plate Systems; 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 single use only; refer to the product label to determine if 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
Prior to use, instruments should be visually inspected for wear and tested to assure they are functioning properly. If instruments are discolored, show evidence of corrosion, have loose screws/pins, are out of alignment, are cracked or have other irregularities, Do Not Use. Instrumentation that appears damaged should be returned to the manufacturer.
