FDA Finds Multiple Quality Failures for 3D-Printed Orthodontic Devices
Failure to maintain complaints and submit medical device reports to the FDA, among other serious quality failures, landed devicemaker Ortho Solutions, doing business as DynaFlex, a Form 483 following an FDA inspection of its Saint Ann, Missouri plant.
The company failed to submit medical device reports within 30 days after becoming aware that devices malfunctioned and “would be likely to cause or contribute to a death or serious injury of the malfunction were to reoccur,” the agency said.
The company received 239 complaints from customers between January 2018 and August 2019. At least five events were not reported to the FDA.