BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIN TO ROD COUPLING HOFFMANN II MRI 4-5/8MM

    MDR report key: 1850340 · Received September 20, 2010

    Report

    Report Number
    8031020-2010-00120
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    KTT
    PMA / PMN Number
    K053472
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES WERE RETAINED BY THE HOSPITAL. IF THE DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, WHEN DOING EXTERNAL FIXATION, THE THREE CLAMPS WERE FROZEN AND WOULD NOT TURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIN TO ROD COUPLING HOFFMANN II MRI 4-5/8MM IMPLANT KTT STRYKER OSTEOSYNTHESIS SELZACH NA W15260/W14255

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other