BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHARITE SIZE 3 ENDPLATE, 50

    MDR report key: 655183 · Received December 22, 2005

    Report

    Report Number
    1526439-2005-00278
    Event Type
    Other
    Date Received
    December 22, 2005
    Date of Event
    December 1, 2005
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MJO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONTACT REPORTS THAT A PT WHO WAS IMPLANTED WITH A CHARITE DISC WITH NO COMPLICATIONS DURING OR AFTER SURGERY EXPIRED LATER THAT DAY. IT WAS POSSIBLY DUE TO AN EMBOLISM. CO'S SALES REP. STATED THAT THE SURGEON DOES NOT CONSIDER THE OUTCOME TO BE DEVICE RELATED. DEPUY SPINE IS TAKING A CONSERVATIVE APPROACH AND FILING AN MDR TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARITE SIZE 3 ENDPLATE, 50 ARTIFICIAL DISC MJO DEPUY SPINE, INC. NA WL040C044

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other