6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM
Received Apr 29, 2025 · Event occurred Apr 17, 2025
Report 9610612-2025-00070 · MDR key 21927355
Device
Generic name
Cranial Fixation
Manufacturer
Aesculap AgModel number
FF016Catalog number
FF016
Lot number
52904345
Product problems
- Loosening of Implant Not Related to Bone-Ingrowth
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
NA · Unknown
- Failure of Implant
- Failure of Implant
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: B5 - DESCRIPTION UPDATED. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED NO LONGER REPORTABLE FOR THE FOLLOWING REASONS: NO SERIOUS PUBLIC HEALTH THREAT / FALSIFIED PRODUCT. NO SERIOUS INCIDENT.
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. 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).