T2 ALPHA 2353-3503Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327338645), received between Sep 9, 2021 and Nov 4, 2024 — classified as 3 malfunctions.

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

• MalfunctionNov 4, 2024Failure to Align; Failure to Align

  AS REPORTED: "DRILL DEVIATED FROM SCREW HOLE DURING LAG SCREW DRILLING. THE GUIDE PINS AND DRILLS WERE REINSERTED MANY TIMES WITH ADJUSTMENTS". THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20595937 ↗
• MalfunctionOct 17, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE NAIL JIG IS MISSING THE NAIL IN THE DISTAL HOLE OF THE NAIL. THIS ADDED 1-1.5 HOURS TO THE CASE CAUSING EVERYTHING TO BE DONE BY HAND.

  Patient problems: Insufficient Information

  MAUDE report 20471177 ↗
• MalfunctionSep 9, 2021Failure to Align; Failure to Align

  IT WAS REPORTED THAT WHEN SETTING INITIAL DEPTH AND VERSION WITH THE MIL FAL THE LAG SCREW K-WIRE, IT KEPT MISSING THE NAIL POSTERIOR AND HIT ONCE PROXIMAL. THIS RESULTED IN A 1-1.5 HOUR SURGICAL DELAY. PRE-TESTING CONFIRMATION OF RECON LAG SCREW TARGETING AT A PRIOR DATE AND THE DEVICE WORKED AS EXPECTED. ANOTHER SURGEON SCRUBBED IN AND ASSISTED THE LOST REDUCTION OF THE FRACTURE AND HELPED COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447255 ↗