NA 60-14008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154183937), received between Apr 27, 2021 and Apr 27, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.

• MalfunctionApr 27, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT DURING THE PROCEDURE, THE SURGEON WAS DRILLING INTO PLATE WITH DRILL IN WHICH THE DRILL BIT CHIPPED OFF THE CHIPPED PIECE COULD NOT BE LOCATED AND A X-RAY WAS DONE POST OPERATIVELY IN WHICH IT WAS STILL NOT LOCATED. THE SURGEON BELIEVES THE PIECE WAS SUCTIONED DURING THE PROCEDURE. THERE IS NO OTHER INFORMATION AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 11732443 ↗