BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANEK PLATE AND SCREW

    MDR report key: 210849 · Received February 19, 1999

    Report

    Report Number
    1030489-1999-00017
    Event Type
    Injury
    Date Received
    February 19, 1999
    Date of Event
    October 2, 1993
    Report Date
    January 21, 1999
    Manufacturer
    SOFAMOR DANEK MANUFACTURING
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED ON 10/04/1991. DUE TO PSEUDOARTHROSIS AND LOOSENING AND/OR BACKING OUT OF THE SCREWS, REVISION SURGERY WAS PERFORMED ON 10/02/1993 TO REPLACE INSTRUMENTATION. DUE TO PSEUDOARTHROSIS AND PRESENCE OF TWO BROKEN SACRAL SCREWS, REVISION SURGERY WAS AGAIN PERFORMED ON 01/24/1995 TO REMOVE AND REPLACE INSTRUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DANEK PLATE AND SCREW Implant BONE PLATE AND SCREW KWQ SOFAMOR DANEK MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention