T2 ALPHA 2353-4105Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327357073), received between Sep 10, 2020 and Apr 27, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Component Missing” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED: "THE ADJUSTING DEVICE COULD NOT BE ATTACHED TO THE DISTAL TARGETING ARM WHEN INSERTING THE DISTAL SCREW WITH THE DISTAL DEVICE. THE PROCEDURE WAS PERFORMED USING A FREEHAND TECHNIQUE." ADDITIONALLY, IT WAS REPORTED; THE PROCEDURE WAS EXTENDED HOWEVER THE LENGTH OF THE EXTENSION IS UNKNOWN AND THERE WAS ADDITIONAL EXPOSURE TO RADIATION.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 14219264 ↗
• MalfunctionFeb 25, 2021Unstable; Unstable

  AS REPORTED: "DURING SURGERY THE ADJUSTING DEVICE (2353-4105) CAN WRIGGLE AT THE TARGETING ARM (2353-4106). IT TURNS OUT THAT A "PIN/SPLIT" HAS FALLEN OUT OF THE ADJUSTING DEVICE AND THEREFORE THE FEATURE OF "LOCKING" THE ADJUSTING DEVICE IN THE TARGETING ARM, IS NOT POSSIBLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11382060 ↗
• MalfunctionOct 19, 2020Component Missing; Failure to Align; Component Missing; Failure to Align

  AS REPORTED: "THE DISTAL ADJUSTING DEVICE PIN WAS MISSING. THE DOCTOR DIDN'T NOTICE IT, AND A DRILL WAS INSERTED IN THE ANKLE SURFACE. MISS DRILLING HAS OCCURRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10701923 ↗
• MalfunctionSep 23, 2020Component Missing; Component Missing

  AS REPORTED: "THE PIN OF ADJUSTING DEVICE (#23534105/LOT 261507) WAS MISSING DURING THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10576687 ↗
• MalfunctionSep 10, 2020Component Missing; Component Missing

  AS REPORTED: "T2 ALPHA TIBIAL BONE, DISASSEMBLING DEVICE ON DISTAL DEVICE WAS NOT STABLE DUE TO GRAZING, AND IT WAS CONFIRMED THAT ONE PIN WAS MISSING. THE PROCEDURE WAS CHANGED TO RADIO ROOT."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10517507 ↗