BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IO FREEDOM

    MDR report key: 20339857 · Received September 30, 2024

    Report

    Report Number
    3007289093-2024-00012
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    August 6, 2024
    Report Date
    September 30, 2024
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HWC
    PMA / PMN Number
    K201556
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IO FREEDOM 6.5 CANNULATED SCREW WAS REMOVED DUE TO PAIN AND POSSIBLE TITANIUM ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947989 IO FREEDOM BONE SCREW HWC EXTREMITY MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention