BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIRSCHNER WIRE Ø1.6X150MM

    MDR report key: 3771495 · Received April 24, 2014

    Report

    Report Number
    0008031020-2014-00208
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    February 17, 2014
    Report Date
    February 17, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K012162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN I&D AND WASHOUT DUE TO POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248989 KIRSCHNER WIRE Ø1.6X150MM PLATE, FIXATION, BONE HRS STRYKER TRAUMA SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention