BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1662329 · Received April 16, 2010

    Report

    Report Number
    1030489-2010-00521
    Event Type
    Injury
    Date Received
    April 16, 2010
    Date of Event
    June 28, 2005
    Report Date
    March 18, 2010
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWQ
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). LITERATURE ARTICLE CITATION: LEE ET AL. INFLUENCE OF ANTERIOR CERVICAL PLATE DESIGN ON DYSPHAGIA. JOURNAL SPINAL DISORDERS AND TECHNIQUES 2005; 18:406-409. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 126 PATIENTS UNDERWENT ANTERIOR CERVICAL FUSION PROCEDURES USING AN ANTERIOR PLATING SYSTEM WITH A LEFT-SIDED APPROACH. ALL PATIENTS WERE IMMOBILIZED IN EITHER A HARD COLLAR OR A TWO-POSTER BRACE POSTOPERATIVELY. SIXTY EIGHT PATIENTS REPORTED DYSPHAGIA AT ONE MONTH POST-OP. FORTY FIVE PATIENTS REPORTED DYSPHAGIA AT 2 MONTHS POST OP. TWENTY SEVEN PATIENTS REPORTED DYSPHAGIA AT 6 MONTHS POST OP. TWENTY PATIENTS REPORTED DYSPHAGIA AT 12 MONTHS POST OP. SIXTEEN PATIENTS REPORTED DYSPHAGIA AT 24 MONTHS POST OP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK