Medtronic product linked to surgery problems
Wall Street Journal (subscription required), September 4, 2008
A potent substance used in spine-repair surgery to promote bone growth has been linked to life-threatening complications in dozens of patients. Many of the complications involving the product, Medtronic Inc.'s "Infuse Bone Graft," have occurred during off label uses. Medtronic representatives said it is taking the reports seriously and has been active in warning doctors of certain problems related to use of the bone graft. They added, however, that the rate of complications is low and that reports to the FDA of problems represent one-tenth of 1% of the units sold.