T2 1845-1036SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540412546), received between Jun 23, 2020 and Dec 28, 2020 — 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 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.

• InjuryDec 28, 2020Fracture; Fracture

  AS REPORTED: "ON (B)(6) 2020 A MALE PATIENT UNDERWENT ORIF PROCEDURE FOR FEMORAL SUBTROCHANTERIC FRACTURE (LEFT SIDE) . AT THAT TIME T2 RECON 10MM AND 360MM WAS USED AS THE PATIENT WAS YOUNG AND THE MEDULLARY CAVITY WAS NARROW. THREE MONTHS AFTER THE OPERATION ON A MEDICAL EXAMINATION, BROKE OF THE NAIL WAS CONFIRMED ON THE DISTAL SIDE OF THE LAG SCREW HOLE. ON (B)(6) 2020, REVISION OF THE NAIL WITH T2 ALPHA-F WAS PERFORMED WITHOUT PROBLEM. DOCTOR'S OPINION: THE REDUCTION WAS RESTORED IN THE FIRST OPERATION, AND REAMING WAS PERFORMED UNTIL 10 MM NAILS WERE INSERTED, AND THERE WAS NO FAILURE WITH THE OPERATION. THE DOCTOR WAS CONVINCED THAT THE NAIL BROKE BECAUSE IT WAS BEFORE THE BONE FUSION. REVISION COMPLETED WITHOUT ANY PROBLEMS."

  Patient problems: Failure of Implant

  MAUDE report 11076660 ↗
• InjuryJun 23, 2020Fracture; Fracture

  AS REPORTED: ON (B)(6) 2019, PRIMARY OPERATION WAS PERFORMED. ON (B)(6) 2020, THE PATIENT COMPLAINED OF PAIN BUT THERE WAS NO CHANGES FOUND BY THE X-RAY. ON (B)(6) 2020, THE BROKEN OF THE NAIL WAS CONFIRMED. ON (B)(6) 2020, THE BROKEN NAIL WAS REMOVED AND FIXED WITH T2SCN LONG.

  Patient problems: Injury

  MAUDE report 10186467 ↗