Trinica® And Trinica® Select Anterior Cervical Plate Systems

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 at level C2-T1. 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:

• Overt infection or distant foci of infections
• Local inflammation, with or without fever or leukocytosis
• Pregnancy
• Diseases or conditions other than those specifically described in the Indications section
• Use in the posterior elements (pedicles) of the cervical, thoracic, or lumbar vertebrae
• Where attempted correction exceeds the limits of physiological conditions
• Uncooperative patient or patient with neurologic disorders rendering the patient incapable of following instructions
• Metabolic disorders that may impair bone formation
• Inadequate bone stock to support the device
• Inability to restrict high activity level
• Obesity
• Poor prognosis for good wound healing (e.g. decubitis ulcer, end-stage diabetes, severe protein deficiency and/or malnutrition)

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.

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:

• Paralysis, complete or incomplete. Delayed onset has occurred even when evoked potential was unaffected during surgery
• Dural tear leading to cerebrospinal fluid fistula or pseudo meningocele
• Other spinal cord injuries not otherwise described due to positioning of the spinal attachment device
• Laminar erosion
• Epidural bleeding
• Abnormal sensations
• Radiculopathy

Possible device postoperative complications/adverse reactions that may require medical or surgical intervention (e.g., implant removal with or without re-instrumentation) include:

• Loosening, bending, breaking, disassembly, and/or migration of the components
• Collapse of a fracture and/or fusion site
• Device failure
• Corrosion at the screw/locking cap interface contributing to breakage, and/or pseudoarthrosis
• Discomfort or pain, soft tissue erosion, or protrusion due to prominent implanted hardware
• Attachment device pullout, especially with short constructs and osteoporotic bone
• Implant or graft extrusion through the skin
• Postural deformities, pain, skin breakdown, or residual neural compression due to kyphosis or lordosis occurring at the top of the segment being instrumented
• Bone loss or fracture due to stress shielding
• Foreign body reaction to the device including tumor formation, autoimmune disease, metallosis, and/or scarring
• Non-union or pseudoarthrosis
• Cessation of growth at the fusion site
• Discitis, arachnoiditis, and/or other types of inflammation

Possible general or local postoperative complications/adverse reactions that may require medical or surgical intervention (e.g., implant removal with or without re-instrumentation) include:

• Hemothorax
• Deep vein thrombosis, thrombophlebitis, and/or pulmonary embolism that may be fatal; may be due to patient position and/or length of the surgical procedure
• Decubitus ulcer
• Wound infection, deep or superficial, which may require implant removal and/or other medical interventions
• Wound dehiscence, delayed wound healing, or hematoma
• Pain, possibly severe in nature
• Urinary tract infection
• Blood vessel damage and/or blood loss or hemorrhage
• Fracture(s) of the bone
• Gastrointestinal, urological, and/or reproductive system compromise including sterility, impotency, and/or loss of consortium
• Bone graft donor site pain
• Inability to resume activities of normal daily living