SMART TSF 71075125Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556745373), received between Dec 9, 2025 and Dec 9, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 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 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A SMART TSF- EXTERNAL FRAMING SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED THE BREAKAGE OF ONE (1) SMART TSF HALF RING 180MM ON UNKNOWN DATE. NO FALL OR MECHANICAL LOAD KNOWN. THE PATIENT DID NOT SUFFER ANY INJURY. THE SURGEON DID NOT MENTION THAT THE PATIENT HAD ANY SYMPTOMS. THIS ADVERSE EVENT WAS SOLVED WITH AN ADDITIONAL SURGERY ON (B)(6) 2025 IN WHICH NEW RINGS WERE APPLIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764229 ↗