TriMed Rebuked on MDRs, CAPAs, After Device Issue Leads to Surgery

TriMed, a maker of implantable bone fixation systems, failed to report a device failure that required surgery to remove the device, according to an FDA warning letter.

In February 2014, the company learned about the breakage of an implanted fixation plate, which was associated with the need for surgery, according to the June 30 letter. But the Santa Clarita, Calif., company had not submitted a report for the event at the time of the FDA’s March 2016 inspection.

Posted on the FDA’s website Aug. 2, the warning letter cites two other complaints that linked the company’s osteotomy device and pin plate with a malfunction. — April Hollis