BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IO FIX

    MDR report key: 10276455 · Received July 15, 2020

    Report

    Report Number
    3007289093-2020-00017
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 10, 2020
    Report Date
    July 15, 2020
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HWC
    PMA / PMN Number
    K121349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED A BROKEN LAG SCREW POSTOPERATIVELY. PATIENT HAD A NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742466 IO FIX BONE SCREW HWC EXTREMITY MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR