BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1567105 · Received December 23, 2009

    Report

    Report Number
    1030489-2009-01236
    Event Type
    Injury
    Date Received
    December 23, 2009
    Date of Event
    November 25, 2009
    Report Date
    December 1, 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 #876-013, 510K #K970806 WAS CLEARED IN THE UNITED STATES. THE EXPLANTED IMPLANT WAS NOT RETURNED. THE PICTURES OF EXPLANTED SCREW AND SOME POST OP X-RAYS HAVE BEEN SENT TO THE MANUFACTURER. THE EVALUATION IS IN PROCESS. FOLLOW UP REPORT WILL BE SENT AFTER THE EVALUATION IS COMPLETED. 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 PATIENT UNDERWENT A PROCEDURE TO FUSE C3-C7 USING ANTERIOR FIXATION PLATE AND SCREWS. IT WAS FOUND THAT THE SCREW AT C3 BACKED OUT POST OP. THE SCREW SHOWED BEING IMPLANTED A LITTLE BIT PROUD AT IMMEDIATE POST OP X-RAYS. THE PATIENT WAS NOT COMPLAINING OF PAIN, HOWEVER THE REVISION SURGERY WAS PERFORMED APPROXIMATELY 14 MONTHS POST OP TO REPLACE THE C3 SCREW. THE BACKED OUT SCREW WAS REPLACED. IT WAS CONFIRMED AT THE REVISION SURGERY THAT THE FUSION WAS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM BONE SCREW KWQ WARSAW ORTHOPEDIC INC. NA W08B3116

    Patients

    Seq Age Sex Outcome Treatment
    1 60+ Required Intervention BONE SCREW, CATALOG# G876H011