SMART TSF 71075710Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556745625), received between Apr 12, 2023 and Apr 12, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanics Altered” (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.

• InjuryApr 12, 2023Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT, AFTER AN EXTERNAL FIXATION PROCEDURE, DURING A POST OPERATORY VISIT IT WAS NOTICED THAT THE SMART FX STRUT SHORT WASN'T LOCKED IN PLACE, AS A RESULT, REDUCTION OF THE FRACTURE WAS LOST. THE FRACTURE WAS REDUCED AGAIN AND THE STRUT WAS CHANGED. NO FURTHER COMPLICATIONS WERE REPORTED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Deformity/ Disfigurement; Nonunion/Delayed-union Bone Fracture

  MAUDE report 16728302 ↗