BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.0MM STERNAL CABLE 750MM

    MDR report key: 1041382 · Received May 12, 2008

    Report

    Report Number
    1719045-2008-00058
    Event Type
    Malfunction
    Date Received
    May 12, 2008
    Report Date
    April 17, 2008
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDQ
    PMA / PMN Number
    K031508
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. SYNTHES IS UNABLE TO DETERMINE THE MFR DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    THE 1.0MM STERNAL CABLES IMPLANTED IN A PT, BROKE POST OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.0MM STERNAL CABLE 750MM STERNAL CABLES JDQ SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI