BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS PLATE

    MDR report key: 234952 · Received August 5, 1999

    Report

    Report Number
    MW1016887
    Event Type
    Injury
    Date Received
    August 5, 1999
    Date of Event
    July 9, 1999
    Report Date
    August 4, 1999
    Manufacturer
    SOFAMOR-DANEK MFG, INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY AND FUSION, C4-5 WITH ATLANTIS PLATE FIXATION. PT BEGAN TO COMPLAIN OF NECK AND SHOULDER PAIN. CT REVEALED SMALL HALO AROUND THE BONE GRAFT AS WELL AS HALO AROUND THE UPPER SCREWS INDICATING PSEUDOARTHROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS PLATE Implant CERVICAL FIXATION PLATE KWQ SOFAMOR-DANEK MFG, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention