T2 ALPHA 2341-1225SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327291063), received between Dec 5, 2020 and Dec 5, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Positioning Failure” (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.

• InjuryDec 5, 2020Positioning Failure; Positioning Failure

  AS REPORTED: OBLIQUE FRACTURE OF THE DISTAL 1/3 OF THE TIBIA. PERFORM FLEXIBLE REAMING UP TO F13 AND INSERT F12 × 255 MM NAILS. AT THE TIME OF NAIL INSERTION, THE CENTRAL BONE FRAGMENT WAS DISPLACED ANTERIORLY AT THE FRACTURED PART, SO A BLOCKING K WIRE WAS INSERTED, BUT AFTER REPOSITIONING, IT WAS INSERTED AGAIN, BUT ANTERIOR DISLOCATION AGAIN. THE POSTERIOR PART OF THE FRACTURE WAS GREATLY CRUSHED, AND THE DOCTOR DECIDED THAT THE T2 ALPHA TIBIAL NAIL COULD NOT MAINTAIN THE REDUCTION POSITION, SO IT WAS CHANGED TO EXTERNAL FIXATION. DOCTOR'S COMMENT: THE SHAPE OF THE NAIL DID NOT MATCH THE SHAPE OF THE PATIENT'S BONE. THE BONE QUALITY WAS TOO WEAK. THE PLATE WILL BE FIXED AT A LATER DATE.

  Patient problems: Limb Fracture

  MAUDE report 10953268 ↗