Trinnect Cervical Allograft Spacers are pre-hydrated in Preservon® technology to provide safety, strength and performance.
Integrity and Integration
The Trinnect Hydrated Anterior Cervical Spacer System is a line of precision-machined cervical allograft spacers. Trinnect Allograft Spacers are processed by LifeNet Health®, which is accredited by the American Association of Tissue Banks (AATB). Trinnect Allograft Spacers are packaged using Preservon®, a glycerol-based preservation technology, allowing the spacer to be stored in a fully hydrated state at ambient temperature, eliminating the need to freeze or freeze-dry the spacers.
Trinnect Allograft Spacers are composed of cortical bone for structural integrity and dense cancellous bone for integration. The graft features two pieces of cortical bone to form the lateral aspects of the graft with cancellous bone in the center.
- Load-bearing cortical edges provide structural integrity while the large cancellous center allows for osteointegration
- Ready for use in under 30 seconds without the need for rehydration
- Composed of two pieces of cortical bone for structural integrity and dense cancellous bone for integration
- Machined with horizontal ridges to provide expulsion resistance
Preservon Allograft Bio-Implant Preservation Technology
- How does it work?
Glycerol, the active ingredient in Preservon, acts as a humectant, maintaining the moisture within the allograft, while providing a bacteriostatic environment.
These properties allow ambient temperature storage of the allograft without decay. Widely used as a food additive, glycerol has been used since 1991 as a carrier in commercially available osteobiologics products to enhance handling characteristics.
- 14.5 x 11.5mm footprint with 5–12mm heights in 1mm increments
- 7° of lordosis to closely approximate the curvature of the cervical spine
ZimVie Spine’s anterior cervical plate products are engineered to treat complex cases with clinical effectiveness, always with a commitment to patient safety.
The Trinnect Hydrated Anterior Cervical 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 for Use
This allograft spacer is intended for implantation.
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.
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.
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.
Zimmer Biomet Spine, Inc.
10225 Westmoor Dr.
Westminster, CO 80021 USA