INSIGNIA ANTERIOR CERVICAL PLATE SYSTEM

Description of Event or Problem

ONE YEAR FOLLOWING SURGERY, RADIOGRAPHIC IMAGING REVEALED TWO SCREW FRACTURES, WITH BOTH SCREWS PARTIALLY BACKING OUT OF THE PLATE. A REVISION SURGERY WAS PERFORMED TO REMOVE THE HARDWARE. THIS IS REPORT 2 OUT OF 2.

Additional Manufacturer Narrative

THE IMPLANTS WERE DISCARDED AT THE HOSPITAL. RADIOGRAPHIC IMAGING WAS PROVIDED WHICH CONFIRMED THE EVENT. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. ALPHATEC SPINE, INC. IS SUBMITTING THIS REPORT IN COMPLIANCE WITH FDA REGULATIONS UNDER 21 CFR 803. ALL RELEVANT AND AVAILABLE INFORMATION WAS INCLUDED TO THE BEST OF OUR KNOWLEDGE AT THE TIME OF THIS SUBMISSION. ANY FIELDS LEFT BLANK REFLECT INFORMATION THAT WAS NOT KNOWN OR NOT PROVIDED.