Zimmer, Inc.
The Trinica and Trinica Select Anterior Cervical Plate Systems are versatile spinal implant systems that provide a full range of plate and screw sizes to ensure a better anatomical fit with little or no contouring required. These anterior cervical plate systems are intended for anterior interbody screw fixation of the cervical spine, and feature the innovative Secure-Twist® Anti-Migration System, which secures up to three screws with a twist of the wrist. It also features All-Through-One instrumentation, which provides a common guide for drilling, tapping and screw placement.
For procedures spanning four levels, Zimmer Spine offers the original Trinica Anterior Cervical Plate System.
ZS-SA0700-24_A
The Trinica and Trinica Select Anterior Cervical Plate Systems consist of cervical plates, locking caps, bone screws, and the instruments necessary to implant this specific system. All implant components are made from a titanium alloy (Ti-6Al-4V). The Trinica and Trinica Select Anterior Cervical Plate Systems are intended to provide stabilization of the cervical vertebra for various indications (see below). The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with self-tapping and self-drilling bone screws using an anterior approach. Bone screws are available for fixed angle or variable angle implantation. The Trinica and Trinica Select Anterior Cervical Plate Systems are intended to be removed after solid fusion has occurred. Refer to the Surgical Technique Manual for additional information on how to use these devices.
The Trinica and Trinica Select Anterior Cervical Plate Systems are intended for anterior interbody screw fixation of the cervical spine. The Systems are indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
WARNING: These devices are not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Contraindications for use of the Trinica and Trinica Select Anterior Cervical Plate Systems include:
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.
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:
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.
Possible neurologic operative/postoperative adverse reactions that may require medical or surgical intervention (e.g., implant removal with or without re-instrumentation) include:
Possible device postoperative complications/adverse reactions that may require medical or surgical intervention (e.g., implant removal with or without re-instrumentation) include:
