SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS
Indications
Magnifuse™ Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone.
Magnifuse™ Bone Graft may be used in a manner comparable to autogenous bone or allograft bone. Magnifuse™ Bone Graft may be mixed with fluid such as bone marrow aspirate, blood, sterile water, or sterile saline in order to adjust the consistency and handling characteristics of the bone graft material. Magnifuse™ Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.
Magnifuse™ II Bone Graft is intended for use as a bone graft substitute in bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. Magnifuse™ II Bone Graft is resorbed/remodeled and replaced by host bone during the healing process.
Contraindications
The following are contraindications for the use of Magnifuse™ DBM Bone Graft and Magnifuse™ II Bone Graft:
- The presence of infection at the transplantation site.
- Treatment of spinal insufficiency fractures.
Caution
This product may contain trace amounts of antibiotics (gentamicin), surfactant, and other solutions used in processing the bone tissue as well as the PGA mesh. Caution should be exercised if the patient is allergic to these antibiotics or chemicals.
Precautions
Extensive donor blood serum testing, medical and social history screening procedures, and tissue microbiological testing have been used in the qualification of all tissue donors. Despite the viral inactivation and extensive tissue donor selection and qualifications process used in providing this tissue graft, transmission of an infectious disease through the use of this tissue graft is still possible. Bacterial infection at the graft site may also occur. Any adverse outcomes potentially attributable to Magnifuse™ or Magnifuse™ II Bone Graft must be reported promptly to Medtronic (i.e., spine, pelvis, and extremities). Adequate fixation should be used to stabilize the implant site during bone formation and healing in bony voids or gaps of the skeletal system.
