T2 1843-0934SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540383709), received between Jul 2, 2018 and Jul 2, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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 2, 2018Break

  IT WAS REPORTED THAT PATIENT'S LEFT FEMUR WAS REVISED APPROXIMATELY 2 MONTHS POST PRIMARY IMPLANT AFTER PATIENT TWISTED WHILE UNREELING A GARDEN HOSE AND BROKE THE IM NAIL APPROXIMATELY 1.5 INCHES PROXIMAL TO THE DISTAL LAG RECON SCREW. PATIENT WAS REVISED TO A COMPETITOR CONSTRUCT.

  Patient problems: Failure of Implant

  MAUDE report 7654988 ↗