Sheehy 1112363Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00681490033671), received between Jan 21, 2022 and Jun 29, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2022Break; Break

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PROSTHESIS BROKE DURING THE OPERATION. ON FOLLOW-UP, IT WAS REPORTED THAT THE PRODUCT WAS BROKEN WHILE BEING USED ON A PATIENT, INTRA-OPERATIVELY. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THE FRAGMENTS WERE NOT REMOVED, THE SURGEON REPAIRED THE BROKEN ITEM BY USING CARTILAGE TO FUSE IT AND INSERTED IT BACK INTO THE MIDDLE EAR OF THE PATIENT. ADDITIONAL INFO RECEIVED. THE PROCEDURE WAS COMPLETED WITHIN 3 HRS. NO UNANTICIPATED MEDICAL INTERVENTIONS, PROCEDURES OR TREATMENTS WERE PERFORMED. THE EVENT OCCURRED DURING A MIDDLE EAR MASTOIDECTOMY; TOTAL REPLACEMENT. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14849741 ↗
• MalfunctionJan 21, 2022Break; Break

  IT WAS REPORTED THAT DURING IMPLANTATION THE DEVICE BROKEN. PRODUCT HAD CONTACTED PATIENT AND NO FRAGMENT LEFT IN PATIENT. THERE WAS NO INJURY TO PATIENT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT AND THERE WAS A SURGICAL DELAY OF 60 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13313387 ↗