BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD OPEN SACRAL SCREW

    MDR report key: 213170 · Received March 4, 1999

    Report

    Report Number
    1030489-1999-00027
    Event Type
    Injury
    Date Received
    March 4, 1999
    Date of Event
    February 26, 1993
    Report Date
    March 1, 1999
    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 2/14/1992. DUE TO PSEUDOARTHROSIS AND FRACTURE OF ONE OF THE SACRAL SCREWS, REVISION SURGERY WAS PERFORMED ON 2/26/1993.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention