BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IO FIX 2.0

    MDR report key: 14027773 · Received April 6, 2022

    Report

    Report Number
    3007289093-2022-00005
    Event Type
    Injury
    Date Received
    April 6, 2022
    Report Date
    November 30, 2021
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HWC
    PMA / PMN Number
    K201556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DEVICE REMOVAL DUE TO NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064752 IO FIX 2.0 BONE SCREW HWC EXTREMITY MEDICAL, LLC. 209717

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention