N/A 1160000Recalls & reported problems
Medtronic Xomed, Inc. · PROSTHESIS 1160000 TI PARTIAL RND 2MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00763000036812), received between Jun 21, 2024 and Jun 21, 2024 — classified as 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.
MalfunctionJun 21, 2024Break; Break
IT WAS REPORTED THAT DURING THE SURGERY, THE TAIL OF THE PRODUCT BROKE OFF WHEN THE PRODUCT WAS IMPLANTED IN THE PATIENT'S BODY. THE SURGEON THEN REMOVED THE BROKEN PART WITH TWEEZERS AND DISCARDED IT. THE SURGERY WAS CONTINUED AFTER THE NEW PRODUCT WAS REPLACED. THE REPORTED EVENT RESULTED IN A PROCEDURE DELAY AND THE EVENT WAS EXTENDED TO 15 MINUTES. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19582016 ↗
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 · TerminatedUniversal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Other PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT devices
- TITANIUM/FLUOROPLASTIC PISTON 409-375Grace Medical, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 recall0 reports
- NA 1150001Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT3 reports
- SMART 70145928Gyrus ACMI, LLC · Prosthesis, Partial Ossicular Replacement3 reports
- NA 1150000Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT2 reports
- The Big Easy® 1156603Medtronic Xomed, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT2 reports
- PARTIAL 3MM CENTERED HEAD 270Grace Medical, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 report
- CENTERED ALTO CONCISE PARTIAL 655-075Grace Medical, Inc. · Prosthesis, Partial Ossicular Replacement1 report
- ECLIPSE FLAT RIBBON PISTON 472-450Grace Medical, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 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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