DORNHOFFER ALTO TOTAL W/SHOE & WINDOWS 626Recalls & reported problems
Grace Medical, Inc. · DORNHOFFER ALTO TOTAL W/SHOE & WINDOWS-SIZERS INCLUDED HA/TITANIUM/SILICONE · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844505006958), received between Nov 21, 2017 and Nov 21, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2017Break; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE DEVICE BROKE WHILE BEING IMPLANTED. THE PHYSICIAN REPORTED THAT THE DEVICE WAS TOO LONG AND NEEDED TO BE ADJUSTED/SHORTENED. SURGERY WAS COMPLETED WITH A REPLACEMENT DEVICE, BUT THE SURGERY WAS DELAYED.
Patient problems: No Code Available
MAUDE report 7050004 ↗
Other REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL devices
- Sheehy 1112363Medtronic Xomed, Inc. · REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL2 reports
- Sheehy 1156363Medtronic Xomed, Inc. · REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL2 reports
- Gyrus ACMI 140964Gyrus ACMI, LLC · Replacement, Ossicular Prosthesis, Total2 reports
- NA 0362Medtronic Xomed, Inc. · REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL1 report
- NA 0550Medtronic Xomed, Inc. · REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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