T2 1822-0830SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540197627), received between Mar 20, 2020 and Mar 20, 2020 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryMar 20, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT TIBIA WAS REVISED DUE TO THE TIBIAL NAIL BREAKING AT THE MOST PROXIMAL DISTAL HOLE OF THE DEVICE WHILE PATIENT WAS WALKING. REPORTED PATIENT FACTORS: DIABETES, DIABETIC NEUROPATHY.

  Patient problems: Failure of Implant; Injury; Neuropathy; Nonunion/Delayed-union Bone Fracture

  MAUDE report 9862851 ↗