6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 - DESCRIPTION UPDATED. H6 - CODES UPDATED. INVESTIGATION RESULTS: THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS BASED UPON BATCH HISTORY REVIEW, HISTORICAL DATA ANALYSIS AND EVENT DESCRIPTION. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) HAVE BEEN CHECKED FOR ALL LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE MENTIONED LOT NUMBERS. 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, ADDITIONAL MEDICAL INTERVENTION. CONCLUSION/PREVENTIVE MEASURES: BASED ON THE CURRENT INFORMATION, A CLEAR CONCLUSION CANNOT BE DRAWN. IN THE EVENT THAT THE COMPLAINT SAMPLE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. THERE IS NO INDICATION FOR A MATERIAL DEFECT OR MANUFACTURING FAILURE. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

Description of Event or Problem

UPDATE: AFTER THE SURGERY, PRESSURE BANDAGING WAS APPLIED TO THE PROBLEMATIC AREA, AND THE PATIENT'S CONDITION IS CURRENTLY STABLE. THERE WAS ONLY ONE (1) COMPLAINED PRODUCT, BUT THE BATCH NUMBER COULD NOT BE DETERMINED. THE PATIENT HARM WAS UPDATED TO ADDITIONAL MEDICAL INTERVENTION, AND NO LONGER REVISION SURGERY. ASSOCIATED MEDWATCH REPORTS FF016/ 6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00069). FF016/ 6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00070). FF016/ 6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00071).

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 FF016 - 6 CRANIOFIX ABSORBABL. CLAMP STERILE 11MM. ACCORDING TO THE COMPLAINT DESCRIPTION, ON THE DAY OF SURGERY, AFTER CLOSING THE SKULL, NO ABNORMALITIES WERE FOUND. APPROXIMATELY TEN (10) DAYS POSTOPERATIVELY, THE BONE FLAP HAD LIFTED. 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 NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG (B)(4). ASSOCIATED MEDWATCH REPORTS FF016/ 6 CRANIOFIX ABSORBABL. CLAMP STERILE 11MM (B)(4). FF016/ 6 CRANIOFIX ABSORBABL. CLAMP STERILE 11MM (B)(4). FF016/ 6 CRANIOFIX ABSORBABL. CLAMP STERILE 11MM (B)(4).