BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNI

    MDR report key: 11991885 · Received June 14, 2021

    Report

    Report Number
    3007289093-2021-00007
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    April 28, 2021
    Report Date
    June 14, 2021
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HRS
    PMA / PMN Number
    K180808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNION WAS ACHIEVED BUT PATIENT HAD DISCOMFORT FROM THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890232 OMNI BONE PLATE HRS EXTREMITY MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention