BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1510179 · Received September 30, 2009

    Report

    Report Number
    1030489-2009-00904
    Event Type
    Malfunction
    Date Received
    September 30, 2009
    Report Date
    August 31, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 876-313, 510K # K970806 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A CERVICAL PROCEDURE AT C4-C7 USING ANTERIOR FIXATION. IT WAS FOUND THAT THE SCREW BACKED OUT ABOUT 2MM AT RIGHT C4 APPROX FIVE MONTHS POST OP. THE PT WAS ASYMPTOMATIC. NO REVISION IS PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM BONE SCREW KWQ WARSAW ORTHOPEDIC INC. NA H08G6544

    Patients

    Seq Age Sex Outcome Treatment
    1