ABC SELF-LOCKING CERVICAL SCREW 4.0X16MM

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PRODUCT FJ933T - ABC SELF-LOCKING CERVICAL SCREW 4.0X16MM. ACCORDING TO THE COMPLAINT DESCRIPTION, INITIAL FIXATION SURGERY OF C3-C7 WAS PERFORMED. TWENTY DAYS LATER, AN X-RAY RESULT ON (B)(6) 2025 SHOWED THAT C7 SCREWS HAD BACKED OUT. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION SURGERY. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4 - LOT NUMBER. D9 - DEVICE RETURN. H3 - YES, EVALUATION. H4- MANUFACTURE DATE. H6 - CODES UPDATED. INVESTIGATION RESULTS: VISUAL INSPECTION: THERE WERE NO DAMAGES OR DEFECTS ON THE TWO ABC SCREWS RECEIVED. THE THREADED BODY OF THE SCREWS SHOW NO DEFECTS LIKE FRACTURES OR SHEARED OF THREADS. THE HEAD OF THE SCREWS ARE IN A FAULTLESS CONDITION, ALL PETALS ARE PRESENT AND NOT BENT OR RUBBED OFF. FURTHERMORE, THE LOCKING MECHANISM IS PRESENT IN BOTH SCREW HEADS. THE TIP OF THE SCREWS HAD NO DAMAGE AND ARE PRACTICALLY IN FLAWLESS CONDITION. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, REVISION SURGERY. CONCLUSION/PREVENTIVE MEASURES: ON THE BASIS OF THE CURRENT INFORMATION, AS WELL AS THE RESULT OF THE INVESTIGATION, A CLEAR CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A DESIGN-, MANUFACTURING- AND/OR MATERIAL-RELATED FAILURE. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.