BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 637374 · Received September 22, 2005

    Report

    Report Number
    637374
    Event Type
    Injury
    Date Received
    September 22, 2005
    Date of Event
    September 16, 2005
    Report Date
    September 19, 2005
    Manufacturer
    JOHNSON AND JOHNSON DEPUY SPINE, INC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD DEGENERATIVE DISK DISEASE OF L5 AND S1. HAD TOTAL DISK REPLACEMENT 08/24/2005. THE DISK DISPLACED ANTERIORLY AND PT HAD TO HAVE ANOTHER SURGERY TO REMOVE IT AND HAVE FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PROSTHETIC DISK MJO JOHNSON AND JOHNSON DEPUY SPINE, INC. * *
    2 * ENDPLATE KWQ JOHNSON AND JOHNSON DEPUY SPINE, INC * WL 048E041
    3 * ENDPLATE KWQ JOHNSON AND JOHNSON DEPUY SPINE, INC * WL 040C051
    4 * SLIDING CORE KWQ JOHNSON AND JOHNSON DEPUY SPINE, INC * WL 042C103

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention