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Defective Medical Devices

Medtronic Infuse Bone Graft Lawsuits

This Alert Affects:

Patients who suffered complications after undergoing a surgery on the upper spine and neck using the Medtronic Infuse bone graft.

Medtronic infuse problems reportedly include swelling of tissue in the neck and throat which can lead to difficulty swallowing and breathing, as well as infection, cyst formation, male infertility and death.
Medtronic Inc.
Additional Details
The Medtronic Infuse bone graft is a bioengineered material which spurs bone growth. The Medtronic Infuse has been approved for lower back surgeries; however, it has not received FDA approval for use in the cervical spine, which extends from the shoulders to the head. Still, many patients have received the Infuse bone graft in cervical spine surgery to treat neck pain.
Type of Lawsuit
Mass Tort

Reportedly, the Medtronic Infuse bone graft can lead to serious complications when it is used in unapproved procedures. The protein has only been FDA-approved for use in lower spine repair surgery to promote bone growth, and when used in cervical spine (upper spine and neck) surgery, may put the patient at risk for Infuse bone graft complications. Infection, cyst formation, male infertility and death are among the serious Medtronic infuse problems reportedly associated with the product.

Medtronic Infuse Problems

Reportedly, studies funded by the manufacturer neglected to disclose serious Medtronic Infuse problems. No infuse bone graft complications were reported in 13 clinical trials funded by the company, while data provided to U.S. regulations and other publications found that up to 50% of patients suffered from Medtronic infuse problems, according to the Spine Journal. Patients are particularly at risk for Infuse bone graft complications when undergoing cervical spine fusions, a procedure for which the product was not FDA-approved.

The following are among the reported Medtronic Infuse problems:

  • Cyst formation
  • Infection
  • Male infertility
  • Cancer
  • Death

The FDA has also received reports of additional Infuse bone graft complications including swelling of the throat and neck tissue, which can lead to difficulty swallowing, breathing or speaking.

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Case Resources

Nisbet et al. v. Medtronic Inc. Complaint
Case number 8:08-cv-01361, U.S. District Court for the Central District of California
FDA Public Health Notification, July 2008
The FDA reminds healthcare professionals that human Bone Morphogenetic Protein (rhBMP) is not approved for use in cervical spine fusion and that the protein may cause life-threatening complications in these surgeries.
The Spine Journal Study, February 2011
Researchers find that use of rhBMP in spinal fusion bone grafts may cause complications and adverse events at rates 10 to 50 times higher than original estimates.