NEXXT MATRIXX INTERBODY SYSTEM

Additional Manufacturer Narrative

A REVIEW OF MANUFACTURING HISTORY RECORDS SHOWS THE PRODUCT WAS RELEASED WITH NO ANOMALIES AND CONFORMING TO DESIGN SPECIFICATIONS. AS PART OF RISK MANAGEMENT, THE CONDITION IS ADDRESSED IN THE IFU AND SURGICAL TECHNIQUE.

Description of Event or Problem

IT WAS REPORTED ON (B)(6) 2018 DURING A SPINAL PROCEDURE A MATRIXX IMPLANT FRACTURED WHILE THE SURGEON WAS TRYING TO ROTATE INTO PLACEMENT. THE SURGEON WAS PUSHING THE IMPLANT BEYOND EXPECTATION AND CAUSED AN EXTREME LOAD AND THE IMPLANT FRACTURED. IT SHOULD BE NOTED, THE TORQUE APPLIED TO THE IMPLANT WAS GREATER THAN THE DESIGN LIMIT.75% TO 80% OF THE DEVICE IS IMPLANTED IN THE DISC SPACE AND THE REMAINDER OF THE DEVICE WAS NOT IMPLANTED AS IT WAS ATTACHED TO THE INSERTING INSTRUMENT. AT NO TIME DURING THE PROCEDURE, DID A FRACTURED PIECE FALL INTO THE PATIENT'S WOUND. THE SURGEON INVESTIGATED AND FOUND THE IMPLANT TO BE SECURE AND WAS PERFORMING AS INTENDED SO IT WAS DECIDED TO LEAVE THE IMPLANT IN PLACE. THERE WAS NO PATIENT INJURY DUE TO THE EVENT. THE REMAINDER OF THE IMPLANT WAS LOST BY THE CENTRAL PROCESSING CENTER AT THE HOSTPITAL AND WILL NOT BE RETURNED TO NEXXT SPINE.