ASCEND NANOTEC VBR SYSTEM

Additional Manufacturer Narrative

THE IMPLANT WAS 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.

Description of Event or Problem

AT THE TWO-MONTH POSTOPERATIVE FOLLOW-UP VISIT, RADIOGRAPHIC IMAGING REVEALED A CAGE MIGRATION. REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE CAGE.