BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LDI FIXATION SCREW

    MDR report key: 196682 · Received November 5, 1998

    Report

    Report Number
    1030489-1998-00081
    Event Type
    Malfunction
    Date Received
    November 5, 1998
    Date of Event
    July 23, 1998
    Report Date
    October 5, 1998
    Manufacturer
    SOFAMOR DANEK EUROPE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE: 03/13/1998. PLATE FIXATION SCREW RETROGRADE. PHYSICIAN REPORTED BONY FUSION NOT COMPLETE. DEVICE HAS NOT BEEN REPORTED TO HAVE BEEN EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR