BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHARITE ENDPLATE SIZE UNKNOWN

    MDR report key: 697931 · Received April 11, 2006

    Report

    Report Number
    1526439-2006-00091
    Event Type
    Malfunction
    Date Received
    April 11, 2006
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MJO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTED HAVING A CHARITE PATIENT 9 MONTHS POST-OP PRESENT WITH LEG PAIN AND TUNIMAL BACK PAIN. EVALUATION OF Z-RAY FOUND WHAT APPEARS TO BE SOM SUBSIDENCE, NOT REMARKABLE. PATIENT WILL MORE THAN LIKELY HAVE A CT/MYLO AND A FORAMINOTOMY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention