BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM CERVICAL PLATE 8 HOLES 60MM

    MDR report key: 1082149 · Received July 25, 2008

    Report

    Report Number
    3005673311-2008-00023
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    May 28, 2008
    Report Date
    July 9, 2008
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    KWQ
    PMA / PMN Number
    K050804
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. BODY OF THE DEVICE WAS IMPLANTED. THE SLIDE LOCK THAT BROKE FROM THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    SURGEON WAS PLACING SCREW INTO HOLE OF SPECTRUM PLATE WHEN THE LOCK MECHANISM POPPED OUT. SURGEON INQUIRED ABOUT PUTTING THE LOCK BACK IN, DECIDED NOT TO AND REMOVED THE SCREW FROM THAT HOLE. THIS WAS IN THE MIDDLE OF A 3 LEVEL CONSTRUCT SO THE SURGEON WAS OK WITH JUST USING ONE SCREW AT THAT LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM CERVICAL PLATE 8 HOLES 60MM KWQ AESCULAP AG & CO. KG FG361T 51305252

    Patients

    Seq Age Sex Outcome Treatment
    1