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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXTREMITY MEDICAL, LLC. OMNI MINI; BONE PLATE
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EXTREMITY MEDICAL, LLC. OMNI MINI; BONE PLATE Back to Search Results
Catalog Number 154-11800
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/06/2025
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that an omni mini plate broke due to patient non-compliance and was removed.Patient was fused.
 
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Brand Name
OMNI MINI
Common Device Name
BONE PLATE
Manufacturer (Section D)
EXTREMITY MEDICAL, LLC.
300 interpace parkway
building a, 2nd floor
parsippany NJ 07054
Manufacturer Contact
mary hoffman
300 interpace parkway
building a, 2nd floor
parsippany, NJ 07504
9735888980
MDR Report Key22470816
Report Number3007289093-2025-00007
Device Sequence Number14489610
Product Code HRS
UDI-Device Identifier00842078124345
UDI-Public(01)00842078124345
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K221362
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Device Explanted Year2025
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/10/2025
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number154-11800
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/12/2025
Initial Report FDA Received Date07/10/2025
Was Device Evaluated by Manufacturer? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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