CANNULATED COMPRESSION HEADLESS SCREW

Additional Manufacturer Narrative

THE COMPLAINT WAS INVESTIGATED AND EVALUATED AIDED BY THE INFORMATION PROVIDED. THE BROKEN DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE EVALUATION WAS UNABLE TO BE COMPLETED. PATIENT RADIOGRAPHS CONFIRMED THE COMPLAINT EVENT OF A BROKEN SCREW AND SUPPLEMENTAL FIXATION. A DHR REVIEW FOR LOT-SPECIFIC DEFECTS WAS NOT ABLE TO BE CONDUCTED AS NO LOT INFORMATION IS AVAILABLE. A HISTORICAL DATA ANALYSIS RETURNED NO TRENDS OR CAPAS ASSOCIATED WITH THIS EVENT TYPE. WHILE THE PATIENT WAS NON-COMPLIANT WITH POST-OPERATIVE INSTRUCTIONS, THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

Description of Event or Problem

THE FOLLOWING EVENT WAS PROVIDED FROM THE RETROSPECTIVE ARM OF A CLINICAL STUDY: FAILED FUSION AND BROKEN HARDWARE. THE SUBJECT HAD AN ADVERSE EVENT AT 3 MONTHS POST OPERATIVE WHERE THE SUBJECT DID NOT FUSE AND WAS SHOWING SIGNS OF (1) SCREW BREAKAGE AND A BROKEN STAPLE (SUPPLEMENTAL FIXATION BREAKAGE, NON-STUDY DEVICE). THE EVENT WAS SEVERE, SERIOUS, HAD A DEFINITE RELATIONSHIP TO THE SUBJECT DEVICE, HOSPITALIZATION WAS REQUIRED, BUT THE PATIENT RECOVERED WITHOUT SEQUELAE. IT WAS NOTED ON THE POST OPERATIVE FOLLOW-UP FORM THAT THE SUBJECT AS NOT COMPLIANT WITH POST OPERATIVE INSTRUCTIONS AND WAS BEING OVER-ACTIVE. THE SUBJECT UNDERWENT REVISION SURGERY ON (B)(6) 2024 (10 MONTHS POST OPERATIVE) WHERE ALL 4 SCREWS WERE REMOVED. THE SUBJECT SEEMS TO BE DOING FINE AS THEY DID NOT RETURN BACK TO THE CLINIC AFTER (B)(6) 2024 FOR ANY MORE FOLLOW-UPS.