BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW, FULLY THREADED 5X45 MM

    MDR report key: 1485621 · Received August 4, 2009

    Report

    Report Number
    9610622-2009-00249
    Event Type
    Malfunction
    Date Received
    August 4, 2009
    Date of Event
    July 10, 2009
    Report Date
    July 10, 2009
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K003018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAME PT EVENT AS MDR 910622-2009-00248 DEVICE REMAINS IMPLANTED. NO EVALUATION WILL BE PERFORMED. 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 THAT, "CALCANEAL SCREW IS ADVANCING INTERIORLY. THE LATERAL CALCANEAL SCREW IS BACKING OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW, FULLY THREADED 5X45 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K507468

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other