BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW, FULLY THREADED 5X42,5 MM

    MDR report key: 2182159 · Received June 23, 2011

    Report

    Report Number
    9610622-2011-00275
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K010801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED. NO EVALUATION WILL BE PERFORMED. SAME PT EVENT AS MDR 9610622-2011-00274.

    Description of Event or Problem · 1

    IT IS REPORTED BY OUR CUSTOMER TO STRYKER KIEL THAT BOTH DISTAL LOOKING SCREW WERE BROKEN. A REVISION SURGERY COULD NOT BE PERFORMED BECAUSE OF THE GENERAL CONDITION OF THE PT. THE PT DIED WITHOUT REMOVING THE NAIL. DUE TO THE GENERAL BAD CONDITION OF THE PT, THIS EVENT IS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW, FULLY THREADED 5X42,5 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other