The FDA has received several hundred adverse event reports from patients receiving the Medtronic Infuse Bone Graft for unapproved, off-label use. The graft was initially approved by FDA for use in lumbar and certain tibial fusions and some oral/dental procedures. Reports indicate that Medtronic heavily promoted use of the product for cervical spine and other unapproved uses, thereby subjecting patients to uses which have not been demonstrated to be safe or effective.
If you or a loved one received a Medtronic Infuse Bone Graft and suffered:
- Compression of airway, necessitating a tracheotomy
- Compression of the neurological structures of the neck
Call an experienced attorney today at 1-800-664-1734 You may be entitled to compensation.