BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1031987 · Received April 18, 2008

    Report

    Report Number
    1030489-2008-00201
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 20, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWQ
    PMA / PMN Number
    K970806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED, PRODUCT RETURN IS NOT POSSIBLE AT THIS TIME. POST OP X-RAYS WERE REVIEWED. C6 DISTAL SCREW BACK OUT IS CONFIRMED. THE X-RAYS SHOW THAT THE C6 SCREW IS A VARIABLE ANGLE SELF-TAPPING SCREW. IT IS POSSIBLE THE LOCKING CAP WAS NOT PROPERLY SEATED DURING TIGHTENING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OSTEOARTHRITIS PATIENT UNDERWENT A CERVICAL PROCEDURE AT C4-C7 USING ALLOGRAFT AND ANTERIOR FIXATION. THREE MONTH POST OP FILMS SHOWS THE DISTAL SCREW BACKED OUT OF THE PLATE. PATIENT IS ASYMPTOMATIC. NO REVISION SURGERY IS PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM SCREW KWQ WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR