GYRUS ACMI 70131321Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925024274), received between May 14, 2021 and May 14, 2021 — classified as 1 injury.

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.

• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED DURING A TYMPANOMASTOIDECTOMY WITH OSSICULOPLASTY PROCEDURE USING A GYRUS TITANIUM PORP PROSTHESIS (FOR THE OSSICULOPLASTY PART OF THE SURGERY), THE PHYSICIAN MISTAKENLY IMPLANTED THE TEMPORARY SIZER PROSTHESIS AND NOT THE PERMANENT PROSTHESIS. THE METAL BOX WITH DIFFERENT SIZE PROSTHESES WAS GIVEN TO THE PHYSICIAN. THE PHYSICIAN PICKED A 2 MM PROSTHESIS AND PROCEEDED TO IMPLANT IN THE MIDDLE EAR AND COMPLETED THE SURGERY. THE PHYSICIAN REPORTS NOT BEING INFORMED DURING THE CASE BY EITHER THE CIRCULATOR OR THE SCRUB NURSE THAT WHAT HE HAD USED WAS A TEMPORARY PROSTHESIS. THIS WAS NOT DISCOVERED UNTIL THE PROCEDURE WAS CONCLUDED AND THE PATIENT WAS ALREADY IN THE RECOVERY ROOM. THREE DAYS LATER, THE PATIENT WAS TAKEN BACK TO SURGERY TO REMOVE THE TEMPORARY IMPLANT AND INSTALL THE PERMANENT IMPLANT. NO ADDITIONAL CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED. THE PHYSICIAN REPORTED HAVING USED A SIMILAR PROSTHESIS RECENTLY. HOWEVER, HAVE NOT USED THIS ITEM REGULARLY TO BE AWARE THAT IT COMES WITH SIZERS AT 2MM, 3MM, ETC., AND THEN AN INDIVIDUAL BOX OF THE APPROPRIATE SIZE IMPLANT IS OPENED TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11824932 ↗