US drug regulators admonished Medtronic Inc for marketing unapproved uses for a spine product in an instruction manual for surgeons, according to a letter released on Tuesday.
The US Food and Drug Administration in a warning letter dated October 1 told the medical device maker that the surgical technique manual describes use of the system "that could significantly affect its safety and effectiveness."
The so-called Satellite Spinal System is composed of spheres inserted between vertebras to stabilize the spine.
The FDA warning letter cited violations including omission of a step for implantation of a bone graft, contrary to the approved use of the device, and faulty and confusing instructions for implantation.
The product has not been officially launched yet and only about 100 manuals were issued, said Medtronic spokesman Bert Kelly.
The company is working on a response to the FDA and has withdrawn the manual, he said.
The FDA issues dozens of warning letters each year and most are resolved without further action. In rare cases, they can lead to product seizures or hold up approval of new products.
In July, Medtronic received an FDA warning letter for not submitting timely reports on injuries linked to drug infusion pumps. – (Reuters Health)
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