Big Easy® Piston 1156603Recalls & reported problems
Medtronic Xomed, Inc. · PROSTHESIS 1156603 PLAT/TI .5MMX4.5MM · Class 2 · Implant
Data updated Oct 16, 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 00763000036577), received between Jun 3, 2025 and Jun 3, 2025 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2025Break; Break
IT WAS REPORTED THE DEVICE WAS NOT WELDED. THERE IS NO KNOWN PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 22132007 ↗
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
- GRACE MEDICAL FLUOROPLASTIC PISTON 402-450Grace Medical, Inc. · PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT1 report
- The Big Easy® 1156602Medtronic Xomed, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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