T2 1828-1138SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540200563), received between Sep 25, 2020 and Sep 25, 2020 — classified as 1 injury.

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

• InjurySep 25, 2020Crack; Crack

  AS REPORTED: NO TRAUMATIC EVENT WAS EXPERIENCED. DEVICE HAS NOT BEEN REMOVED OR REPLACED. ADDITIONALLY REPORTED 2-SEP-2020. "THE IMPLANT I WAS INFORMED HAS FAILED WITHOUT ANY SUPPOSED TRAUMATIC EVENT TO THE SURGERY POST PROCEDURE." "THE DEVICE IS SCHEDULED TO BE REMOVED TODAY." "THE NAIL HAS BEEN REMOVED AND THERE IS AN APPARENT CRACK IN THE PROXIMAL END OF THE NAIL WITH ONE OF THE SCREWS BROKEN" UPON RECEIPT OF PRODUCT, 2 OTHER SCREWS WERE FOUND BENT AND HIGHLY WORN (PORTIONS OF THREADS DETACHED / MISSING).

  Patient problems: Failure of Implant

  MAUDE report 10585734 ↗