Medtronic – Infuse Bone Graft
Linked to Life-Threatening Complications
The FDA recently warned surgeons that it had received reports of life-threatening complications associated with using Medtronic’s “Infuse Bone Graft” in surgeries on the cervical spine.
The FDA further stated that 38 reports have been received over the past 4 years of side effects associated with the Infuse Bone Graft. Some patients reported difficulty swallowing, breathing and speaking. Several patients required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries. Many of these complications occurred during “off-label” uses. Off-label means that the surgeons used the device in ways that weren’t approved by the FDA.
Cellino & Barnes is evaluating cases of people who may have suffered as a result of receiving an Infuse Bone Graft after a cervical spinal surgery. If you or a loved one suffered an injury, call us now at (800) 888-8888 or contact us.
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