PARTIAL 3MM CENTERED HEAD 270Recalls & reported problems
Grace Medical, Inc. · PARTIAL 3MM CENTERED HEAD 1.12MM ID X 6MM L HA/OTOSIL · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844505000413), received between Aug 13, 2026 and Aug 13, 2026 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Break
Implant broke when attempting to insert.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50237501 ↗
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- The Big Easy® 1156602Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 report
- N/A 1160000Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 report
- CENTERED ALTO CONCISE PARTIAL 655-075Grace Medical, Inc. · Prosthesis, Partial Ossicular Replacement1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.