Indications
The implant is indicated for bony voids or gaps that are not intrinsic to the stability of bony structures. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The implant is indicated to be gently packed into bony voids or gaps of the skeletal system (extremities and pelvis) un-hydrated or in conjunction with bone marrow aspirate or autogenous blood, or in the posterolateral spine in conjunction with bone marrow aspirate and autograft bone as a bone graft extender. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Contraindications
Use of the implant is contraindicated in the presence of one or more of the following conditions:
- Fractures of the epiphyseal plate.
- Metabolic or systemic bone disorders that affect bone or wound healing.
- Fractures for which stabilization of the fracture is not possible.
- Significant vascular impairment proximal to the graft site.
- Infected or contaminated wounds, or fractures for which intraoperative soft tissue coverage is not planned or possible.
- Acute and chronic infections in the surgical area (soft tissue infections; inflammatory, bacterial bone disorders, osteomyelitis).
- Impaired calcium metabolism.
- Treatment with steroids and other drugs affecting calcium metabolism.
- Immunosuppressant therapy.
- Use in the area of the open epiphyseal growth plate.
- Patients allergic to porcine collagen products.
Warnings
- Standard internal fixation techniques such as the use of plates and/or screws must be followed to obtain rigid stabilization. the implant does not possess sufficient mechanical strength to support the reduction of a fracture site prior to soft and
- hard tissue in-growth or to support a load.
- External stabilization alone is not sufficient to achieve the rigidity necessary for bony in-growth of the the implant material.
- Do not use the implant to gain screw purchase or to stabilize screw placement. Screws used with the implant and fixation devices must attain rigid fixation int the host bone.
- Do not use the implant where complete soft tissue coverage cannot be achieved.
- This system has not been evaluated for safety and compatibility in the MR environment. This system has not been tested for heating or migration in the MR environment.
Precautions
- The implant is intended for use only by surgeons familiar with bone grafting and rigid fixation techniques.
- The implant is radiopaque, so the radiopacity may mask underlying pathological conditions.
- The implant is intended for single use only.
- Always follow recommended hydration instructions when rehydrating the implant.
- Do not apply the implant dry to the posterolateral spine.
- Avoid overfilling the defect site.
- Ensure that after cutting or shaping, any shaped device surfaces are smooth and free from excessive loose particles.
- Do not resterilize the implant.
- Discard any un-used the implant.
- Do not expose the implant to temperature extremes such as freezing or excessive heat.
- Postoperative patient management should follow the same regimen as similar cases utilizing autogenous bone grafting. Standard postoperative practices should be followed, particularly as applicable to defect repairs involving the use of fixation devices.
See product specific surgical technique manual and package insert for complete instructions and labeling limitations.
