BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAUMACEM V+ CEMENT KIT 10 ML

    MDR report key: 2900743 · Received January 8, 2013

    Report

    Report Number
    8030965-2013-00064
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Report Date
    December 10, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: WHILE MIXING THE CEMENT ALL FOUR HANDLES OF THE MIXER BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9880 TRAUMACEM V+ CEMENT KIT 10 ML TRAUMACEM V+ CEMENT KIT NDN SYNTHES GMBH 1C53031

    Patients

    Seq Age Sex Outcome Treatment
    1