BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_OSTEOSYNTHESIS_PRODUCT

    MDR report key: 4011888 · Received August 15, 2014

    Report

    Report Number
    0008031020-2014-00378
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    July 20, 2014
    Report Date
    July 24, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K050512
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPETITOR DEVICE WITH UNKNOWN CAT# AND LOT# WAS NOT AFFECTED BY THIS EVENT AND DID NOT CONTRIBUTE TO THE FAILURE. IF ANY NEW INFORMATION IS AVAILABLE THE COMPLAINT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE SURGEON AND HEAD OF THE ORTHOPAEDICS WARD REPORTED VIA SALES REP THAT HE PERFORMED A SURGERY OF EXTRACTION OF AXSOS PLATE TOGETHER WITH SCREWS. CUSTOMER REPORTED THAT THERE WAS A NEED FOR SURGERY DUE TO THE FACT THAT SCREWS WERE FOUND TO BE IN TISSUES AND SEPARATED FROM THE PLATE. FOUR SCREWS HEADS SEPARATED FROM THE THREADS. AS PER THE CUSTOMER THE ENTIRE PLATE WAS PLACED TOO PROXIMALLY. SURGEON ALSO OBSERVED SECONDARY DAMAGE TO THE DISTAL END OF THE FEMORAL BONE.

    Description of Event or Problem · 1

    THE SURGEON AND HEAD OF THE ORTHOPAEDICS WARD REPORTED VIA SALES REP THAT HE PERFORMED A SURGERY OF EXTRACTION OF AXSOS PLATE TOGETHER WITH SCREWS. CUSTOMER REPORTED THAT THERE WAS A NEED FOR SURGERY DUE TO THE FACT THAT SCREWS WERE FOUND TO BE IN TISSUES AND SEPARATED FROM THE PLATE. FOUR SCREWS HEADS SEPARATED FROM THE THREADS. AS PER THE CUSTOMER THE ENTIRE PLATE WAS PLACED TOO PROXIMALLY. SURGEON ALSO OBSERVED SECONDARY DAMAGE TO THE DISTAL END OF THE FEMORAL BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489836 UNKNOWN_OSTEOSYNTHESIS_PRODUCT PLATE, FIXATION, BONE HRS STRYKER TRAUMA SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention