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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.

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Published on Jul-2-08


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