NA 91-14326Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540504173), received between Jun 29, 2023 and Jun 29, 2023 — 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.

• MalfunctionJun 29, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "WHILE DRILLING TO INSERT A SCREW, THE TIP OF THE DRILL BROKE OFF AND REMAINED IN THE PATIENT BONE."

  Patient problems: Foreign Body In Patient

  MAUDE report 17224594 ↗