T2 1822-0015SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540197573), received between Sep 29, 2015 and Sep 29, 2015 — classified as 1 death.

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.

• DeathSep 29, 2015Fracture

  IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT WENT INTO VA HOSPITAL FOR A COUMADIN APPOINTMENT AND DUE TO BLEEDING COMPLICATIONS PATIENT WAS TRANSFERRED TO A NON-VA HOSPITAL. THEY TRIED TO RECOVER HIM FROM THAT ISSUE, GIVING HIM BLOOD TRANSFUSION AND FRESH FROZEN PLASMA. PATIENT WAS PUT IN ICU. ON THIRD NIGHT, IN WEE HOURS OF THE MORNING, PATIENT FELL OUT OF BED. RAILS WERE RAISED. PATIENT FELL ON 20TH [MONTH UNKNOWN]. PATIENT BROKE HIS HIP AND HIS SHOULDER. SURGERY OCCURRED ON THE 23RD [MONTH UNKNOWN]. HIP ONLY SURGERY. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT PASSED AWAY FOUR DAYS AFTERWARDS. NO AUTOPSY PERFORMED.

  Patient problems: Bone Fracture(s); Death; Fall; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 5110695 ↗