The U.S. Food and Drug Administration has cited several violations by an orthopedic medical devices startup that produces implants and screws used for orthopedic surgery on hands, wrists, feet and ankles in a warning letter to the company.
Among the infractions by Extremity Medical cited in the warning letter dated Feb. 24 were two cases in which the company failed to submit a product experience report to the U.S. regulator after it became aware that a device it markets may have caused or contributed to a death or serious injury.
“For example PER #11-074 refers to a broken lag screw at the joint of a Hallux device. If the device breaks after implantation, as described in PER #11-074, and there is no revision surgery, then the malfunction may result in a non-union of the patient’s joint. The malfunction of a longterm implant is a reportable event per Comment 12 of the 1995 Final Rule for Medical Device Reporting.”
In an inspection of Extremity Medical’s facilities between September and October last year, the FDA found other violations mentioned in the letter, including a failure to establish internal systems to provide timely transmission of complete medical device reports. It also noted the company’s move to revise its surgical guide for using its IO Fix Intra Osseous Fixation device without notifying the FDA following incidents involving the devices during surgical procedures.
The distribution of the revised surgical technique was initiated to reduce a risk to health posed by the device because the events described in PER-10-040, PER-10-041 and PER-10-043 constitute a risk to health.
The FDA letter also cited the company over changes made to some of its devices without notifying the agency of its intent to distribute them commercially. The FDA said it would evaluate the information submitted by the company to determine whether they can be legally marketed. Additionally, the regulator said the company failed to conform with good manufacturing practices.
The company could face regulatory action if it does not respond to the letter within 15 days.
Extremity Medical was started in 2008 in Parsippany, New Jersey and funded by Blue Slate Solutions LLC, an Albany, New York accelerator.