BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3971721 · Received July 31, 2014

    Report

    Report Number
    3025141-2014-00182
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 1, 2014
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    PMA / PMN Number
    K944330
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DUAL-TRAK SCREW WAS EXPLANTED FROM THE CLAVICLE DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447884 SCREW, FIXATION, BONE HWC ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention