6 CRANIOFIX BURR HOLE CLAMP ABSORB.16MM

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 FF017 - 6 CRANIOFIX BURR HOLE CLAMP ABSORB.16MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PATIENT WAS DIAGNOSED POSTOPERATIVELY WITH POSSIBLE SUBCUTANEOUS GRANULOMA, SUSPICIOUSLY DUE TO ALLERGY TO MATERIAL. THE GRANULOMA IS SCHEDULED TO BE REMOVED. THE INITIAL SURGERY WAS ON (B)(6) 2021. 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. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H4 - MANUFACTURE DATE H6 - CODES UPDATED INVESTIGATION RESULTS: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INVESTIGATION WAS BASED UPON BATCH HISTORY REVIEW, HISTORICAL DATA ANALYSIS, AND EVENT DESCRIPTION. 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, ADDITIONAL MEDICAL INTERVENTION. CONCLUSION/ PREVENTIVE MEASURES: BASED ON THE CURRENT INFORMATION, A CLEAR CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A DESIGN-, MANUFACTURING- AND/OR MATERIAL-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT SAMPLE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. POLY (LACTIC ACID) OR POLYLACTIDE (PLA) AND ITS COPOLYMERS HAVE BEEN IN CLINICAL USE FOR MANY YEARS AND HAVE BEEN PROVEN TO BE BIOCOMPATIBLE AND SAFE. INFLAMMATORY REACTIONS TO THE MPLANT ARE CLOSE TO THE IMPLANTED MATERIAL AND NOT SYSTEMIC IN NATURE. THE OVERALL COMPLAINT DATA SUGGEST THAT NO PRODUCT RELATED SYSTEMATIC ERROR WITH THE CFA EXISTS. THE REPORTABLE EVENTS RECORDED FOR COMPARABLE PRODUCTS INDICATE PATIENT-DEPENDENT VARIATIONS (FOR EXAMPLE CLEARING CAPACITY OF THE TISSUES) RATHER THAN PRODUCT-DEPENDENT VARIATIONS THAT MAY HAVE LED TO ALTERED DEGRADATION KINETICS. INVESTIGATION OF EXPLANTED CRANIOFFIX ABSORBABLE (CFA) PRODUCTS DO NOT SEEM MEANINGFUL SINCE THE GREATEST PART OF THE DISCS HAVE ALREADY BEEN RESORBED AT THE TIME POINT OF THE ONSET OF SWELLING REACTION AND ONLY FRAGMENTS REMAIN. ADDITIONALLY, THE DESCRIBED SIDE EFFECTS OF DELAYED INFLAMMATORY REACTION ARE MOST LIKELY TO BE RELATED TO INADEQUATE DEGRADATION KINETICS OF CHEMICAL COMPONENTS, RATHER THAN TO POTENTIALLY TOXIC IMPURITIES WITHIN THE PRODUCT. VARIATIONS IN DEGRADATION KINETICS ARE MULTI-FACTORIAL AND HARD TO ASSESS. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.