Medtronic Inc. is in trouble for marketing its Satellite Spinal System for an unapproved use. On October 1, the Food & Drug Administration sent the company a letter that warned that an instruction manual for the medical device suggests using the Satellite Spinal System in ways that represent a “major” change from approved uses.
The Satellite Spinal System consists of spheres that can be inserted between spinal vertebras. The system is intended to stabilize and hold together parts of spinal vertebrae while they heal. This is accomplished by fusing the device to a bone graft. But according to the FDA warning letter, Medtronic’s manual describes a nonfusion procedure without implantation of a bone graft. The FDA letter says that using the device in this way could “significantly affect its safety or effectiveness.” The FDA warning letter also cited other violations, including faulty and confusing instructions for the implantation of the Satellite Spinal System.
The Satellite Spinal System was approved for use this year and has been has been used in less than 1,000 surgeries. Only about 100 of the manuals cited by the FDA letter have been sent out, according to Medtronic. A spokesperson for Medtronic told Reuters that it is trying to figure out how the manual ended up with faulty information. The company said it would withdraw the manual.
The same FDA warning letter also faults Medtronic for announcing the availability of another spinal device in the US prior to its approval. In a press release dated September 27, 2006, Medtronic said that the Arcuate Vertebral Augmentation System was available, even though it was not approved for marketing until March 2007. The FDA letter also states that the press release made claims about the system for which the company did not obtain clearance.
The FDA has ordered Medtronic to stop distributing the manuals for the Satellite Spinal System, and the company has 15 days to respond in writing to the warning letter. The FDA letter says that if Medtronic fails to correct the violations cited in the warning letter, the company could be subject to regulatory action, including seizure, injunction or civil penalties.
In July, the FDA issued a warning letter to Medtronic for not promptly reporting problems with some of its medical devices that may have caused serious injury or death. The July warning letter detailed problems at a Minnesota plant that makes drug infusion pumps and neurostimulation devices. Both products are often used to treat chronic pain and neurological disorders. Medtronic has since said that the problems leading to that warning letter have been resolved.
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