BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.0MM STERNAL CABLE 750MM

    MDR report key: 1041381 · Received May 12, 2008

    Report

    Report Number
    1719045-2008-00057
    Event Type
    Malfunction
    Date Received
    May 12, 2008
    Report Date
    April 17, 2008
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDQ
    Product Problem
    Yes
    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 1.0 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