NA 0250080311Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327052848), received between Dec 26, 2019 and Feb 9, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2022Material Fragmentation; Device Fell; Material Fragmentation

  IT WAS REPORTED THAT SCREW FELL OUT AND POTENTIALLY REMAINED INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502178 ↗
• InjuryJul 22, 2020Break

  IT WAS REPORTED THAT A BROKEN PIECE OF THE DEVICE WAS LEFT INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10310931 ↗
• InjuryDec 26, 2019Break; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A POTENTIAL FOR PIECES OF THE DEVICE BEING LEFT IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9522217 ↗