T2 2339-1317SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327293326), received between Nov 4, 2022 and Nov 4, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (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 16, 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.

• MalfunctionNov 4, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT AFTER ANESTHESIA IT WAS FOUND THAT THE IMPLANT HAD NOT BEEN DELIVERED, AND ANESTHESIA TIME WAS PROLONGED UNTIL THE IMPLANT WAS DELIVERED. TWO AND A HALF HOURS LATER, THE SURGERY BEGAN. ADDITIONAL INFO: THE IMPLANTS WERE NOT READY AT THE START OF SURGERY DUE TO AN ORDERING ERROR BY THE SALES REP. THE SURGERY TIME WAS EXTENDED, BUT THERE WAS NO ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 15724344 ↗