T2 ALPHA 2360-5050SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327366235), received between Mar 1, 2022 and Sep 7, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2022Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE PATIENT WAS 3-MONTHS STATUS POST ANTEGRADE NAILING OF A LEFT PROXIMAL FEMORAL SUBTROCHANTERIC FRACTURE. THE PATIENT HAD A SCREW DISENGAGEMENT OF BOTH OF THE DISTAL INTERLOCKS WITH PAINFUL HARDWARE. THIS RESULTED IN THE DEVICE BEING REMOVED.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 15369545 ↗
• MalfunctionMar 1, 2022Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THE "T2 ALPHA 5MM LOCKING SCREWS BENT WHILE APPLYING COMPRESSION." **UPDATE: THIS INCIDENT HAPPENED DURING T2 ALPHA TIBIAL NAIL. THE BENT SCREW HAD TO BE REMOVED BEFORE PROCEEDING WITH THE SURGERY. THE SURGERY WAS COMPLETED BUT THERE WAS A DELAY WITH REMOVING THE BENT SCREW AND PROCEEDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13635964 ↗