BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL NAIL, A/R T2 FEMUR ? 10X360MM

    MDR report key: 2689197 · Received August 3, 2012

    Report

    Report Number
    9610622-2012-00348
    Event Type
    Injury
    Date Received
    August 3, 2012
    Date of Event
    July 29, 2009
    Report Date
    July 20, 2012
    Manufacturer
    STRYKER TRAUMA GMBH
    Product Code
    HSB
    PMA / PMN Number
    K010801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED FOR EVAL. IF THE DEVICE OR ADD¿L INFO BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. ASSOCIATED DEVICES: 1896-5050S LOCKING SCREW, FULLY THREADED T2 TIBIA?, 5X50 MM LOT # K186251, 1896-5040S LOCKING SCREW, FULLY THREADED T2 TIBIA ? 5X40 MM LOT # K159361, 1896-5045S LOCKING SCREW, FULLY THREADED T2 TIBIA ?5X45MM LOT # K188113, 1896-5045S LOCKING SCREW, FULLY THREADED T 2 TIBIA? 5X45 MM LOT # K188113. SAME PT AS MDR 9610622-2012-00347.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH A CLAIM FOR DAMAGES REGARDING A SURGICAL PROCEDURE OF REDUCTION AND STABILIZATION WITH OSTEOSYNTHESIS PERFORMED IN THE HOSPITAL ON (B)(6) 2009 DUE TO BILATERAL FEMORAL FRACTURE. THE PT PRESUMABLY EXPERIENCED INFECTION BECAUSE THE REQUEST OF THE HOSPITAL IS RELATED TO STERILIZATION PROCEDURE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL NAIL, A/R T2 FEMUR ? 10X360MM IMPLANT HSB STRYKER TRAUMA GMBH NA K994158

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R