FDA 483 - Alphatec Spine, Inc. - April 19, 2017

Alphatec Spine, Inc., a medical device manufacturer in Carlsbad, CA, was cited for inadequate risk analysis during an FDA inspection. The firm failed to properly evaluate risks associated with its Arsenal Set Screw, which experienced malfunctions, disengagement, and serious injuries, leading to MDR reportable events. Despite these issues, a field action was not extended to all affected product populations, leaving potentially faulty devices in the market.