BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARITE ARTIFICIAL DISC, SIZE UNK

    MDR report key: 1012951 · Received March 13, 2008

    Report

    Report Number
    1526439-2008-00066
    Event Type
    Injury
    Date Received
    March 13, 2008
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MJO
    PMA / PMN Number
    P040006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    LITTLE INFO IS KNOWN 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 INFO PROVIDED WITH THE DEVICE.

    Description of Event or Problem · 1

    DEPUY SPINE LEGAL DEPT WAS MADE AWARE OF LEGAL ACTION BEING TAKEN BY A CHARITE ARTIFICIAL DISC PT. PT WAS IMPLANTED WITH CHARITE DISCS IN 2005. DOCUMENT CLAIMS THAT X-RAYS TAKEN IN 2006, REVEALED THAT THE IMPLANT HAD FAILED. PT IS REPORTED TO HAVE UNDERGONE A SERIES OF PROCEDURES TO REMOVE THE CHARITE DISC AND A FUSION BE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention