BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANEK PLATE AND SCREW

    MDR report key: 210884 · Received February 19, 1999

    Report

    Report Number
    1030489-1999-00014
    Event Type
    Injury
    Date Received
    February 19, 1999
    Date of Event
    September 20, 1994
    Report Date
    January 21, 1999
    Manufacturer
    SOFAMOR DANEK MANUFACTURING
    Product Code
    KWQ
    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 11/30/1990. REVISION SURGERY WAS PERFORMED ON 09/20/1994 AT WHICH TIME PSEUDOARTHROSIS WAS OBSERVED AND LOOSE SCREWS WERE FOUND. INSTRUMENTATION WAS REPLACED AND BONE GRAFT PLACED. REVISION SURGERY WAS PERFORMED ON 12/17/1994 DUE TO LOOSE SACRAL SCREWS. DEEP INFECTION WAS FOUND IN THE SACRAL SCREW REGION. INSTRUMENTATION REPLACED. REVISION SURGERY WAS AGAIN PERFORMED ON 04/25/1995 TO REMOVE 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 50 YR Required Intervention