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CRANIOPLATE FM992TRecalls & reported problems

Aesculap AG · CRANIOPLATE 1.5 KIT 4MM CROS.BURR.COVER · Class 2 · Implant

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963173852), received between Oct 21, 2021 and Oct 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1

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.

  • MalfunctionOct 21, 2021Break; Break

    IT WAS REPORTED TO AESULAP AG THAT A CRANIOPLATE 1.5 KIT 4MM CROS.BURR.COVER (PART # FM992T) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE TAIL CAP OF A SCREW WAS BROKEN DURING SURGICAL FIXATION. THE PHYSICIAN REPLACED THE UPPER SCREW TOOL AND WAS ABLE TO CONTINUE AND SUCCESSFULLY COMPLETE THE PROCEDURE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12673429 ↗

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Sources and updates

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