NA 310.23SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982186270), received between Jul 26, 2018 and Jul 26, 2018 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 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.

• InjuryJul 26, 2018Break; Break

  IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE ON AN UNKNOWN DATE, THE TIP OF THE 2.5MM DRILL BIT BROKE OFF WHEN THE SURGEON WAS DRILLING INTO THE PATIENT¿S ILIUM. THE SURGEON DECIDED TO LEAVE IT IN PLACE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY AND NO HARM TO THE PATIENT. THIS REPORT IS FOR A 2.5MM DRILL BIT/QC/GOLD/180MM STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7722834 ↗