BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1586226 · Received January 22, 2010

    Report

    Report Number
    1030489-2010-00086
    Event Type
    Injury
    Date Received
    January 22, 2010
    Date of Event
    December 28, 2009
    Report Date
    December 25, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WHO HAD THE HERNIATED DISC UNDERWENT A CERVICAL PROCEDURE IMPLANTING ANTERIOR FIXATION PLATE AND SCREWS. ONE OF THE SCREWS BACKED OUT AT UNK TIME POST OP. THE REVISION SURGERY WAS PERFORMED APPROX THREE YEARS POST OP TO REVISE THE BACKED OUT SCREW. AT THE REVISION SURGERY IT WAS FOUND THAT THE TREATED LEVEL WAS FUSED. THEREFORE, THE CONSTRUCT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM BONE SCREW KWQ WARSAW ORTHOPEDIC INC. NA W05A6209

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention