The FDA filed a formal warning against New Jersey-based orthopedics maker Extremity Medical for failures in device surveillance and malfunction reporting.
The federal watchdog agency noted 2 instances of device malfunction "that may have caused or contributed to a death or serious injury" and which were not reported to the FDA within the 30-day window.
Extremity filed a response but it was not reviewed because it was not received within 15 days of the FDA’s initial inspection report, according to the warning letter.
The inspectors also found that certain IO Fix intraosseous fixation lag screws and x-posts were mis-branded and that changes made to product designs required that Extremity file new premarket notification applications with the FDA.
"Modifying a screw’s design from a solid design to a cannulated design constitutes a change in the device that could significantly affect the safety or effectiveness of the device," according to the letter.
The warning, filed February 24 but released online this week, came 4 days before Extremity celebrated its 2,000th implantation with its IO FiX intraosseous fixation systems, which it launched globally in June 2011, according to a press release.
The device is a proprietary internal fixation system currently focused on joints in the foot and ankle. Fixation systems for upper extremities are in limited release, but may hit global markets this year.
Extremity Medical declined to comment on the warning letter.
