BEUDAMED
    FDA Adverse Event Death Summary report: N

    CHARITE ARTIFICIAL DISC, SIZE UNKNOWN

    MDR report key: 878645 · Received July 11, 2007

    Report

    Report Number
    1526439-2007-00196
    Event Type
    Death
    Date Received
    July 11, 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. USING TWO CHARITE IMPLANTS IN ONE PATIENT IS AN OFF LABEL USE. CHARITE IS APPROVED FOR USE AS A ONE LEVEL IMPLANT ONLY. SURGEON IMPLANTED TWO DISCS. THIS GOES AGAINST THE INFORMATION THAT IS RECOMMENDED IN THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH EACH DEVICE.

    Description of Event or Problem · 1

    DEPUY SPIN LEGAL DEPT WAS MADE AWARE OF LEGAL ACTION BEING TAKEN BY A CHARITE ARTIFICIAL DISC PATIENT. PATIENT WAS IMPLANTED WITH CHARITE DISCS IN 2006 AT L4/5 AND L5/S. PATIENT IS REPORTED TO HAVE CONTINUED PAIN. FOLLOWING THE IMPLANTATION, PT CONTINUED SUFFERING SEVERE, RADIATING AND DEBILITATING BACK AND LEG 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