Trinnect^® Anterior Cervical Spacer System

Integrity and Integration

• Two pieces of cortical bone form the lateral aspects of the spacer for structural integrity; cancellous bone in the center facilitates integration

Safety, Strength and Performance

• Preservon allograft bio-implant preservation technology retains mechanical strength by eliminating potential brittleness associated with freeze drying
• Confirmed safety and non-toxic response
• Comparable compressive strength and osteoconductivity vs. frozen and freeze-dried bio-implants
• Ready to use in less than 30 seconds without hydration, reducing costly OR time

Product Description

This allograft spacer was processed from donated human tissue, resulting from the generous gift of an individual or his/her family. The spacer was cleaned and disinfected through a proprietary process and terminally sterilized via gamma irradiation. There are two preservation methods included in these instructions: Freeze-Dried, and packaged with Preservon^®. Please refer to the label to identify which preservation method was utilized for this spacer.

Indications

This allograft spacer is intended for implantation.

Contraindications

The contraindications include, but are not limited to: Use in any patient who has a known or suspected allergy to any of the antibiotics and/or processing reagents listed in this package insert.

Warnings and Precautions

The same medical/surgical conditions or complications that apply to any surgical procedure may occur during or following implantation. The surgeon is responsible for informing the patient of the risks associated with their treatment and the possibility of complications or adverse reactions. As with any allograft spacer, the transmission of infectious agents exists. This spacer may contain residuals of antibiotics (Bacitracin, Gentamicin, and/or Polymyxin B Sulfate), alcohol, surfactants, and/or glycerol. Caution should be exercised if the patient has a known sensitivity to any of these antibiotics and/or reagents.

Adverse Events

Potential adverse events or outcomes include, but are not limited to, disease transmission, infection, allograft tissue rejection, allergic reaction to residual processing reagents, reoperation and/or death. Promptly report any adverse event(s) or outcome(s) potentially attributable to the allograft spacer (See COMPLAINTS AND RETURNS section).