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CRANIOFIX2 FF491TRecalls & reported problems

Aesculap AG · CRANIOFIX 2 TITANIUM CLAMP 16MM · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653379583), received between Mar 31, 2021 and Apr 13, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (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

Device problems

  • Loss of Osseointegration1
  • Tear, Rip or Hole in Device Packaging1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionApr 13, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FF491T - CRANIOFIX 2 TITANIUM CLAMP 16MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PACKAGING OF THE DEVICE TEAR DURING SURGERY. THE STERILE PACKAGES HAVE BEEN TEARING WHEN THE CIRCULATION NURSE ATTEMPTED TO OPEN AND PLACE ON THE STERILE FIELD. THERE WAS NO DESCRIBED PATIENT HARM. THERE WAS A TEN - FIFTEEN MINUTE DELAY DUE TO THE REPORTED EVENT. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11655631 ↗
  • InjuryMar 31, 2021Loss of Osseointegration; Loss of Osseointegration

    IT WAS REPORTED TO AESCULAP (B)(4) THAT A CRANIOFIX 2 TITANIUM CLAMP 16MM (PART # FF491T) WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE UPPER CLAMP DISENGAGED FOUR (4) DAYS POST SURGERY. REPORTEDLY, FOLLOWING THE SURGERY, THE UPPER CLAMP DISENGAGED FROM THE ARTIFICIAL SKULL FLAP AND MOVED. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 11599761 ↗

Other PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE devices

All PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.