T2 1828-0934SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540200280), received between Feb 6, 2023 and Aug 7, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "PATIENT IS AN INMATE, INCIDENT OCCURRED WHILE PLAYING BASKETBALL RESULTING IN THE BROKEN NAIL. PATIENT IS ALSO HEPATITIS C POSITIVE. ORIGINAL NAIL RESULTS IN A NON-UNION, ORIGINAL T2 FEMUR A/R NAIL EXPLANTED AND T2 SCN IMPLANTED. THE PROXIMAL PORTION OF THE T2 FEMUR A/R REMAINED IN THE PATIENT." IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN.

  Patient problems: Failure of Implant; Foreign Body In Patient; Implant Pain; Nonunion/Delayed-union Bone Fracture; Viral Infection

  MAUDE report 17469308 ↗
• InjuryFeb 6, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A T2 AR NAIL BENT, POST 3 MONTHS NON WEIGHT BEARING, FOLLOWED BY 6 WEEKS OF WALKING. THIS RESULTED IN A REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 16308854 ↗