Request Legal Help Now - Free

LAWSUITS NEWS & LEGAL INFORMATION

Life-Threatening Complications Associated with Medtronic, Stryker Bone Graft Products


FDA Notes the Products are Being used Off-Label

The FDA has just reported that it's received 38 reports of complications over the past four years resulting from the off-label use of Medtronic Inc.'s InFuse Bone Graft and Stryker Corp.'s OP-1 Implant and OP-1 Putty in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking.

So far, the cause is unknown and characteristics of patients at increased risk have not been identified. Most complications occurred between two and 14 days post-operatively with only a few events occurring prior to day two. When airway complications occurred, medical intervention was frequently necessary.

Legal Help

If you or a loved one has suffered injury or damages from this product, please click the link below to send your complaint to a lawyer to evaluate your claim at no cost or obligation.
Published on Jul-2-08


ADD YOUR COMMENT ON THIS ISSUE

Fields marked * are mandatory. Please read our comment guidelines before posting.

*Name:

Note: Your name will be published with your comment.

*Email Address:

Your email will only be used if a response is needed.
*Your Comment:

Are you the defendant or a subject matter expert on this topic with an opposing viewpoint? We'd love to hear your comments here as well, or if you'd like to contact us for an interview please submit your details here.

Request Legal Help Now! - Free