BEUDAMED
    FDA Adverse Event Death Summary report: N

    CHARITE ARTIFICIAL DISC, SIZE UNKNOWN

    MDR report key: 880003 · Received July 13, 2007

    Report

    Report Number
    1526439-2007-00223
    Event Type
    Death
    Date Received
    July 13, 2007
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MJO
    PMA / PMN Number
    P040006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE CONCLUSIONS CAN BE MADE. AT THIS TIME NO CONNECTION CAN BE MADE BETWEEN THE EVENT AND ANY SHORTCOMINGS OF THE DEVICE OR INFORMATION PROVIDED WITH THE DEVICE.

    Description of Event or Problem · 1

    THE COMPANY WAS MADE AWARE OF LEGAL ACTION BEING TAKEN BY A CHARITE ARTIFICIAL DISC PATIENT. PATIENT WAS IMPLANTED WITH CHARITE DISC IN 2005, AT SPINAL LOCATION L5/S1. PATIENT IS REPORTED TO HAVE CONTINUED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARITE ARTIFICIAL DISC, SIZE UNKNOWN ARTIFICIAL DISC MJO DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention