NA 2358-3105Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327346473), received between Sep 23, 2020 and Sep 23, 2020 — classified as 1 injury.

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.

• InjurySep 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON TREATED A CHRONIC CHARCOT FOOT IN A MEDIAL COLUMN PROCEDURE AND PROVIDED THE FOLLOWING FEEDBACK: ¿CROWN DRILL AND BONE PLUG SEEMED INTUITIVE BUT IT WAS A LITTLE STRUGGLE.¿ ADDITIONAL INFO RECEIVED: "THE STRUGGLE WITH THE CROWN DRILL / BONE PLUG EXTRACTOR WAS IT WAS TOO BIG FOR THE PATIENT AND FRACTURED THE PROXIMAL PORTION OF THE 1ST MET HEAD. IT DID NOT ALTER THE OUTCOME OF THE CASE."

  Patient problems: Bone Fracture(s)

  MAUDE report 10576685 ↗