T2 ALPHA 2341-1228SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327291254), received between Dec 20, 2022 and Dec 20, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 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.

• InjuryDec 20, 2022Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ALS BACKED OUT FROM THE T2 ALPHA TIBIAL NAIL. THE PATIENT HAS A HISTORY OF STROKE AND IS ON DIALYSIS DUE TO DIABETES. THE SUBJECT ADVANCED LOCKING SCREW WAS INSERTED IN THE FOURTH HOLE FROM THE PROXIMAL, BUT THERE WAS ALMOST NO ENGAGEMENT BETWEEN THE SCREW AND CORTICAL BONE DUE TO OVERLAP WITH THE SCREW HOLE POSITION AT THE PRIMARY SURGERY. THE PRIMARY SURGERY WAS PERFORMED WITH ANOTHER COMPANIES' NAIL AND THE REVISION SURGERY WAS PERFORMED WITH T2 ALPHA ON (B)(6) 2022, BECAUSE OF PSEUDARTHROSIS. IN ADDITION, THE PATIENT DID NOT LISTEN TO THE SURGEON'S INSTRUCTIONS ON MOVEMENT RESTRICTIONS, ETC. ONLY THE SCREW THAT BACKED OUT WAS REMOVED ON (B)(6) 2022.

  Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture

  MAUDE report 16019528 ↗