Skip to content

CRANIOFIX2 FF492TRecalls & reported problems

Aesculap AG · CRANIOFIX 2 TITANIUM CLAMP 20MM · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653402243), received between Dec 20, 2021 and Dec 20, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Defective Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Defective Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 20, 2021Defective Component; Defective Component

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REVEALED THAT "THE SURGEON USED CRANIOFIX TO FIX HIS BONE FLAP. HE TIGHTENED IT TO HOLD IT IN PLACE, BUT WHEN HE CUT THE STEM, THE TOP OF THE CRANIOFIX JUMPED OFF." SUBSEQUENTLY, THE PHYSICIAN HAD TO USE "MORE CRANIOFIX." AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13047805 ↗

Other PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE devices

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

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page