The off label use of Medtronic Infuse(R) bone graft has been associated with severe side effects including in some cases, death.
Medtronic Infuse(R) Bone Graft What is It?
Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. designed and marketed the Infuse(R) Bone Graft device (“Infuse(R)”) for lumbar spine surgery. Infuse(R) is a bio-engineered bone filling material containing a bone morphogenetic protein (“BMP”), and is used as an alternative to grafting a patient’s own bone.