INSIGNIA ANTERIOR CERVICAL PLATE SYSTEM

Description of Event or Problem

AROUND 6 MONTHS POSTOPERATIVELY, RADIOGRAPHIC IMAGING REVEALED A SCREW BACKING OUT OF THE PLATE AND SCREW SHANK FRACTURE.

Additional Manufacturer Narrative

THE IMPLANT REMAINS IN SITU. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON INFORMATION PROVIDED, 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.