BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH TITANIUM IMPLANT, STYLE AND SIZE UNKNOWN

    MDR report key: 1161177 · Received September 15, 2008

    Report

    Report Number
    1526439-2008-00166
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    September 6, 2006
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K010576
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    LITTLE INFO WAS PROVIDED. AS A RESULT AN INVESTIGATION COULD NOT BE COMPLETED AT THIS TIME. NO CONCLUSIONS CAN BE MADE AT THIS TIME. DEVICE IS INTENDED TO BE A TEMPORARY FIXATION DEVICE TO AID IN THE PROCESS OF FUSION, AND BREAKAGE CAN OCCUR DUE TO DELAYED UNION OR NON-UNION, AS WELL AS CYCLICAL LOADING OF THE DEVICE OVER TIME. NOTCHES, SCRATCHES OR BENDING OF THE IMPLANT DURING THE COURSE OF SURGERY MAY ALSO CONTRIBUTE TO EARLY FAILURE. THESE PRECAUTIONS ARE STATED IN THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE DEVICE.

    Description of Event or Problem · 1

    DEPUY SPINE WAS MADE AWARE OF LEGAL ACTION BEING TAKEN BY A PT WHO HAD A FUSION IN 2005. FEW DETAILS WERE PROVIDED. PT WAS IMPLANTED WITH TITANIUM MONARCH HARDWARE. DETAILS IMPLY THAT A PRODUCT (SCREW) BROKE/FRACTURED OR SEPARATED CAUSING PT TO SUFFER PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARCH TITANIUM IMPLANT, STYLE AND SIZE UNKNOWN FIXATION DEVICE KWP DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention