T2 ALPHA 2333-0932SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327286489), received between Feb 1, 2022 and Jul 2, 2024 — classified as 2 injuries, 1 malfunction.

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.

• InjuryJul 2, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED, ORIF WAS PERFORMED ON (B)(6) 2023 AND THE T2 ALPHA GT NAIL WAS IMPLANTED IN THE RIGHT FEMUR OF THE PATIENT. ON (B)(6) 2024, THE NAIL BREAKAGE WAS CONFIRMED. THE DOCTOR'S OPINION IS THAT THE NAIL WAS BROKEN BECAUSE THE LOAD MAY HAVE BEEN APPLIED ON THE NAIL DUE TO THE PSEUDARTHROSIS. THE REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2024.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 19652778 ↗
• InjurySep 8, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "(B)(6) 2022 ORIF WITH T2ALPHAGT NAIL WAS PERFORMED. 3 MONTHS AFTER SURGERY, THE NAIL WAS BROKEN. ON (B)(6) 2022, THE BROKEN NAIL WAS REMOVED AND THE FRACTURE WAS RE-FIXED WITH T2ALPHAGT. THE SURGEON'S OPINION WAS THAT THE INITIAL SURGERY NAIL WAS TOO THIN AND SHORT FOR THE PATIENT'S BONE, WHICH MAY HAVE LED TO THE IMPLANT FRACTURE."

  Patient problems: Failure of Implant

  MAUDE report 15377749 ↗
• MalfunctionFeb 1, 2022Positioning Failure; Positioning Failure

  AS REPORTED: "DURING VERIFYING CORRECT ALIGNMENT BY INSERTING A DRILL THROUGH THE SLEEVE AND TARGETING ARM ASSEMBLY, THE DRILL DID NOT PASS THROUGH THE APPROPRIATE HOLE OF THE NAIL (FIRST NAIL). AFTER THAT SOME ADJUSTMENT WAS DONE BUT THE ISSUE DID NOT SOLVE. THE PHYSICIAN CHANGED TO NEW DIFFERENT SIZE NAIL (SECOND NAIL) AND THE VERIFICATION OF CORRECT ALIGNMENT WAS SUCCESSFUL. THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM USING SECOND NAIL WHICH WAS DIFFERENT SIZE AS THE PLANED SIZE NAIL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13418978 ↗