BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, FULLY THREADED S2 ? 5X45MM

    MDR report key: 2832990 · Received October 30, 2012

    Report

    Report Number
    9610622-2012-00484
    Event Type
    Injury
    Date Received
    October 30, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 15, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032579
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IF THE DEVICE OR ADD'L INFO BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PHARMACIST AT THE HOSPITAL, REPORTED THE FOLLOWING EVENT: "THE LOCKING SCREW FRACTURED INSIDE THE PT'S FEMUR. IT WAS IMPOSSIBLE TO EXTRACT THE NAIL. FEMORAL BONE FRACTURED WHILE ATTEMPTING TO EXTRACT THE NAIL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW, FULLY THREADED S2 ? 5X45MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K112740

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R