INISGNIA ANTERIOR CERVICAL PLATE SYSTEM

Additional Manufacturer Narrative

THE IMPLANT DID NOT RETURN FOR EVALUATION. 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. SHOULD ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

Description of Event or Problem

APPROXIMATELY ONE YEAR POSTOPERATIVELY, A RADIOGRAPH IMAGING REVEALED FRACTURED SCREW. REVISION SURGERY WAS PERFORMED TO REMOVE THE HARDWARE.