CRANIOFIX® ABSORBABLE FF017Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653348404), received between Nov 16, 2021 and Jan 3, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2022Product Quality Problem; Product Quality Problem

  IT WAS REPORTED TO AESCULAP AG THAT A 6 CRANIOFIX BURR HOLE CLAMP ABSORB.16MM. (PART # FF017) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPRING INSIDE OF THE HANDLE WAS NOT RELEASED DURING THE FINAL TIGHTENING OPERATION. REPORTEDLY, THE PRODUCT WAS DAMAGED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PATIENT HARM IS UNKNOWN. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 9610612-2021-00792 - 400538941; 9610612-2021-00793 - 400538942.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142137 ↗
• InjuryNov 16, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO AESCULAP AG THAT A 6 CRANIOFIX BURR HOLE CLAMP ABSORB.16MM (PART # FF017) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, FOLLOWING THE SURGERY, BRAIN SWELLING OCCURRED, WHICH PUSHED THE FLAP UP FROM WITHIN THE SKULL AND LED TO THE ABSORBABLE COMING OFF. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820813 ↗