Infuse Bone Graft
The Medtronic Infuse Bone Graft is manufactured and sold by Medtronic, Inc. The Infuse Bone Graft has been approved for use in lower spine-repair surgery to promote bone growth. Recently Infuse has been linked to several cases of death or life-threatening complications when used in surgeries on the upper spine and neck or other unapproved procedures. It is alleged that surgeons with financial ties to Medtronic promoted the use of the protein unofficially in a number of unapproved settings, and complications have included bone growths near nerves or in areas not targeted by the therapy. This has resulted in additional medical interventions and in some cases emergency surgery. While doctors are permitted to use approved medical devices in any way they see fit, it is illegal for manufactures like Medtronic to actively promote such uses.
On July 1, 2008 the FDA issued a public health warning to surgeons about reports of life-threatening complications associated with the use of the Infuse Bone Graft in surgeries on the cervical spine, around the neck.
The FDA had also received at least 38 reports of complications during the past four years associated with its use in cervical spine fusions, for which it is not approved. The complications included swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Other reports describe difficulty swallowing, breathing or speaking.
If you or a loved one have been injured as a result of the Medtronic Infuse Bone Graft you may be entitled to compensation.
TRADEMARK NOTICE: Sprint Fidelis is a trademark of Medtronic Corporation.
The Carabin & Shaw Law Firm, its' lawyers and this website is in no way affiliated with Medtronic Corporation. The use of this mark is solely for informational and product identification purposes.
Other Medtronic recall information:
Call today for a Free Consultation: Have your potential claim reviewed by our Injury Lawyers. If you or a loved one received a defibrillator any where from 2004 to now could have a recalled lead wire issue. Approximately 268,000 Medtronic Sprint Fidelis leads have been implanted worldwide, with about 172,000 in the United States.
The Medtronic recall includes the following model numbers:
- Model 6930
- Model 6931
- Model 6948
- Model 6949



