BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARITE ARTIFICIAL DISC, SIZE UNKNOWN

    MDR report key: 1213306 · Received October 27, 2008

    Report

    Report Number
    1526439-2008-00181
    Event Type
    Injury
    Date Received
    October 27, 2008
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MJO
    PMA / PMN Number
    P040006
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILS ARE LIMITED AT THIS TIME. 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 COMPMANY, WAS MADE AWARE OF LEGAL ACTION BEING TAKEN BY A CHARITE ARTIFICIAL DISC PATIENT. PATIENT WAS IMPLANTED WITH CHARITE DISC IN 2004, AT L5/S1. PATIENT REPORTS HAVING CONTINUED PAIN. AS AN ADVERSE OUTCOME WAS REPORTED AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention