BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARITE ARTIFICIAL DISC

    MDR report key: 1051740 · Received May 21, 2008

    Report

    Report Number
    1526439-2008-00110
    Event Type
    Injury
    Date Received
    May 21, 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
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE MADE AT THIS TIME. EVENT CANNOT BE ATTRIBUTED TO ANY SHORTCOMING OF THE DEVICE OR INFO SUPPLIED WITH THE DEVICE AT THIS TIME.

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH CHARITE DISC IN 2005 AT L4/5 WITH EXCELLENT RESULTS. HE LATER DEVELOPED DDD AT ADJACENT LEVEL L5/S1. HE WAS IMPLANTED WITH PRO DISC IN 2007. PT HAS HAD PAIN AND SURGEON TOLD HIM THAT IT COULD BE RELATED TO SCAR TISSUE RELATED TO PRIOR ARTIFICIAL DISC IMPLANTATIONS. AS THIS COULD RESULT IN THE NEED FOR SURGICAL INTERVENTION AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention