The U.S. Food and Drug Administration provided the Star Tribune with a long-lost database of postsurgical complications following 1,039 surgeries using Medtronic's Infuse product. Most cases were in the lower back, where the product is approved for some uses, but more than 100 were in the upper spine, where use is "off label" and complications can be life-threatening. Some patients had multiple complications.
Related: Lost Medtronic data showed serious risks with Infuse surgical implant
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