The Big Easy® 1156603Recalls & reported problems
Medtronic Xomed, Inc. · PROSTHESIS 1156603 PLAT/TI .5MMX4.5MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00721902848216), received between Aug 4, 2023 and Aug 18, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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
- 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.
MalfunctionAug 18, 2025Break; Break
IT WAS REPORTED THAT PRIOR TO USE, WHEN PREPARING TO IMPLANT THE PRODUCT, IT WAS FOUND THAT THE PRODUCT WAS DEFORMED AND COULD NOT BE USED NORMALLY. THE PACKAGE WAS NOT FOUND TO BE DAMAGED WHEN OPENED. THE PROCEDURE WAS EXTENDED UP TO 3 MINUTES. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT INJURY IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22836288 ↗MalfunctionAug 4, 2023Break; Break
IT WAS REPORTED THAT DURING THE OPERATION WHEN THE OSSICULAR PROSTHESIS NEEDED TO BE IMPLANTED, THE PROSTHESIS BROKE. THE PRODUCT HAVE CONTACT WITH A PATIENT WHO WAS AFFECTED WITH INFECTIOUS DISEASE HIV (HUMAN IMMUNODEFICIENCY VIRUS). THE ISSUE OCCURRED DURING PRE-OPERATION MANIPULATION OF THE DEVICE INSIDE THE SURGICAL FIELD. THE PROCEDURE WAS DELAYED BY 20 MINUTES. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT.THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17456997 ↗
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
- 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
- N/A 1160000Medtronic 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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