BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS

    MDR report key: 223749 · Received May 13, 1999

    Report

    Report Number
    MW1016324
    Event Type
    Malfunction
    Date Received
    May 13, 1999
    Date of Event
    November 13, 1998
    Manufacturer
    DANEK MEDICAL, 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 ACD AT CERVICAL 5-6. HE CONTINUED TO COMPLAIN OF NECK PAIN. MYELOGRAM REVEALED A HALO AROUND THE BONE GRAFT. RE-OPERATION WAS PERFORMED ON 4/8/99, AND A SYNTHES PLATE INTERNAL FIXATION AT CERVICAL 5-6 WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS Implant CERVICAL PLATE KWQ DANEK MEDICAL, INC. 876125 *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR