Gyrus ACMI 140964Recalls & reported problems
Gyrus ACMI, LLC · GOLDENBERG MALLEABLE PORP PROSTHESIS PARTIALLY CANNULATED PLASTI-PORE SHAFT DENSE HYDROXYLAPATITE HEAD · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821925017429), received between Jun 7, 2024 and Oct 22, 2024 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2024Break; Break
IT WAS REPORTED, THE IMPLANT BROKE WHILE TRYING TO IMPLANT IN THE MIDDLE EAR. THE EVENT OCCURRED DURING A TYMPANOPLASTY WITH OSSICULAR CHAIN RECONSTRUCTION PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE WITH NO DELAY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20501575 ↗MalfunctionJun 7, 2024Break; Break
IT WAS REPORTED THE GOLDENBERG MALLEABLE PORP PROSTHESIS WHEN TAKEN OUT OF THE BOX AND WHEN SURGEON PICKED IT UP IT FELL APART. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19483881 ↗
Other Replacement, Ossicular Prosthesis, Total devices
- Sheehy 1156363Medtronic Xomed, Inc. · REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL2 reports
- Sheehy 1112363Medtronic Xomed, Inc. · REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL2 reports
- NA 0550Medtronic Xomed, Inc. · REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL1 report
- NA 0362Medtronic Xomed, Inc. · REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL1 report
- DORNHOFFER ALTO TOTAL W/SHOE & WINDOWS 626Grace Medical, Inc. · REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.