BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEMENT RESTRICTOR, SIZE 12

    MDR report key: 997151 · Received February 8, 2008

    Report

    Report Number
    MW5005352
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 15, 2008
    Report Date
    February 8, 2008
    Manufacturer
    TEKNIMED SA, ZA DE MONTREDON
    Product Code
    ---
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FRAGMENTS OF THE CEMENT PLUG WERE PUSHED OUT OF THE BONE DURING INSERTION OF BONE CEMENT INTO THE HUMERUS. X-RAY INDICATED THAT BONE CEMENT WAS NOT BLOCKED WHERE INTENDED. THE SURGEON INDICATED THAT HE CONSIDERED THIS A "SIGNIFICANT ADVERSE EVENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEMENT RESTRICTOR, SIZE 12 --- TEKNIMED SA, ZA DE MONTREDON 77/0647-12

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other