BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARITE ARTIFICIAL DISC, SIZE UNK

    MDR report key: 1058600 · Received June 2, 2008

    Report

    Report Number
    1526439-2008-00112
    Event Type
    Injury
    Date Received
    June 2, 2008
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MJO
    PMA / PMN Number
    P040006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    LITTLE INFO IS KNOWN AT THIS TIME. NO CONNECTION CAN BE MADE BETWEEN THE REPORTED EVENT AND ANY SHORTCOMING OF THE DEVICE OR INFO SUPPLIED WITH THE DEVICE AT THIS TIME.

    Description of Event or Problem · 1

    DEPUY SPINE INC. RECEIVED A LETTER FROM FDA IN REGARD TO A REPORTED ADVERSE EVENT. SEE ATTACHED HARD COPY FOR FULL DETAILS. PT REPORTED BEING IMPLANTED WITH THE CHARITE ARTIFICIAL DISC IN 2005 AT L4/5. PT COMPLAINS OF CONTINUED PAIN AND HAVING TWO POST CHARITE PROCEDURES. ALSO REPORTS TO NEEDING A FOURTH PROCEDURE IN THE NEAR FUTURE. CLAIMS ALSO TO HEAR A CLICKING NOISE AND X-RAYS SHOW THE WIRE OF THE SLIDING CORE "TO HAVE A PIECE MISSING" (CORE IS C SHAPED). A REVIEW OF RECORDS COULD NOT MATCH THIS EVENT TO ANY PREVIOUSLY REPORTED EVENT. INFO (PT ID, SURGEON NAME) IS LIMITED AND NO FURTHER DETAILS CAN BE GATHERED. AS AN ADVERSE OUTCOME HAS BEEN 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 UNK ARTIFICIAL DISC MJO DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention