NA 60-15920Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154183975), received between Aug 13, 2020 and Aug 13, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionAug 13, 2020Fracture; Fracture

  IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT THE DEVICE SNAPPED AS THE SURGEON WAS PULLING THE DRILL BIT OUT AND THE OTHER BECAME STUCK IN THE BONE AS THEY WERE DRILLING IN THE MANDIBLE AND SNAPPED OFF OF THE SHAFT. DRILL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. NO OTHER INFORMATION IS KNOWN AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10404876 ↗