BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD SCREW

    MDR report key: 170104 · Received May 29, 1998

    Report

    Report Number
    1030489-1998-00027
    Event Type
    Injury
    Date Received
    May 29, 1998
    Date of Event
    December 22, 1992
    Report Date
    April 29, 1998
    Manufacturer
    SOFAMOR DANEK EUROPE
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED ON 12/22/1992. PT COMPLAINS OF SEVERE AND CONSTANT BACK PAIN. X-RAYS REVEAL THAT THE SCREW AT L5 EXTENDS INTO THE L4-5 DISC SPACE. THE DEVICE HAS NOT BEEN EXPLANTED. X-RAYS INDICATE FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD SCREW Implant BONE SCREW KWP SOFAMOR DANEK EUROPE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other