T2 1826-1136SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540378996), received between Oct 1, 2015 and Oct 1, 2015 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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.

• InjuryOct 1, 2015Loss of or Failure to Bond

  IT WAS REPORTED THAT IMPLANTS WERE EXPLANTED FROM PATIENT'S LEFT FEMUR DUE TO INFECTION AND NON-UNION. THE SURGEON DID NOT FEEL THE INFECTION WAS CAUSED BY THE IMPLANT HOWEVER DUE TO THE INFECTION IT WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 5116423 ↗