BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARITE ARTIFICIAL DISC, SIZE UNK

    MDR report key: 1012351 · Received February 12, 2008

    Report

    Report Number
    1526439-2008-00065
    Event Type
    Injury
    Date Received
    February 12, 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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS APPROVED FOR INSERTION AT L4-S1 IMPLANTATION OF THE DEVICE AT L3/L4 GOES AGAINST THE RECOMMENDATIONS MADE IN THE SURGICAL TECHNIQUE, THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH EACH DEVICE AS WELL AS THE INFO PRESENTED AT THE TIME OF SURGEON TRAINING. USING TWO CHARITE IMPLANTS IN ONE PATIENT IS ALSO AN OFF LABEL USE. CHARITE IS APPROVED FOR USE AS A ONE LEVEL IMPLANT ONLY. NO DEFINITIVE CONCLUSIONS CAN BE MADE. THE CAUSE OF THE PATIENTS CURRENT CONDITION CANNOT BE DETERMINED AT THIS TIME. 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 PATIENT. PATIENT WAS IMPLANTED AS A CONTROL SUBJECT IN A CLINICAL TRIAL BEING CONDUCTED BY SPINAL MOTION IN 2005. PATIENT HAD DDD AT L4/5. CLAIM STATES THAT THE SURGEON FAILED TO USE FLUOROSCOPY AND REMOVED A HEALTHY DISC AT L3/4. HE THEN IMPLANTED CHARITE AT L3/5 & L4/5. PATIENT HAS HAD CONTINUED PAIN AND COMPLICATIONS FOLLOWING SURGERY.

    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 29 YR Required Intervention