NA 1150000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00681490909891), received between Oct 2, 2019 and Jul 1, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K002897); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT DURING LEFT TYMPANOPLASTY INSIDE THE EAR CANAL, WHILE THE DOCTOR WAS PLACING THE PROSTHESIS, IT FRACTURED. THE DOCTOR DECIDED TO REMOVE THE ROUND HEAD, LEAVING THE PROSTHESIS SHOE INSIDE THE PATIENT'S EAR. THE PROCEDURE WAS EXTENDED UPTO 2 HOURS. THE PROCEDURE WAS NOT COMPLETED. THE DOCTOR LEFT THE SHOE INSIDE THE EAR BUT REMOVED THE REST OF THE PROSTHESIS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642008 ↗
• MalfunctionOct 2, 2019Material Separation; Material Separation

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE FOOT ON THE ACTUAL IMPLANT BROKE OFF DURING A MASTOIDECTOMY WITH OSSICULAR CHAIN RECONSTRUCTION PROCEDURE. IT WAS NOTED THAT THE DEVICE WAS NOT BROKEN BEFORE THE SURGEON TRIED TO PLACE THE IMPLANT. THE DEVICE BROKE INTO TWO PIECES, THE FOOTPLATE BROKE OFF AS THE SURGEON TRIED TO PLACE IT, BUT BOTH PIECES WERE RECOVERED. THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9145324 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002897. One submission often covers many models, so check the product and lot details in each record.

• Z-2284-2013 · Aug 23, 2013 · Terminated
  Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.