BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1325958 · Received January 14, 2009

    Report

    Report Number
    1030489-2009-00031
    Event Type
    Malfunction
    Date Received
    January 14, 2009
    Date of Event
    December 15, 2008
    Report Date
    December 15, 2008
    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

    NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. THE SUSPECT DEVICES IN USE ARE LOT # W08D0500 AND # W08F3389. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. IN ADDITION, THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 876-613, 510K # K970806 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACDF AT C4/5 USING CERVICAL PLATE AND SCREWS AS ANTERIOR FIXATION. IT WAS FOUND THAT ONE SCREW BACKED OUT AT C5 APPROXIMATELY THREE MONTHS POST OP. NO REVISION SURGERY IS REPORTED 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1