NA 5400071057Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540487445), received between Jul 24, 2018 and Jul 24, 2018 — 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

Recent adverse event reports

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

• MalfunctionJul 24, 2018Break; Break

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE BROKE DURING USE. THERE WAS PATIENT INVOLVEMENT. TWO EVENTS OCCURRED DURING A CRANIAL PROCEDURE WHILE CREATING TACK HOLES ON A PART OF THE SKULL ON THE BACK UP TABLE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7714601 ↗