NA 60-16007Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540356505), received between Jul 31, 2024 and Sep 4, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE BROKE DURING SURGERY. SURGEON LOCATED AND REMOVED THE BROKEN DEVICE. A SURGICAL DELAY OF 180 MINUTES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20141011 ↗
• InjuryJul 31, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY, WHILE MILLING THE BONE TO REMOVE A SCREW, THE DEVICE BROKE IN THE SURGICAL ZONE. THERE IS A MISSING PIECE OF THE DEVICE THAT COULD NOT BE LOCATED IN THE SURGICAL SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19876346 ↗