BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR CERVICAL PLATE SYSTEM

    MDR report key: 1662328 · Received April 16, 2010

    Report

    Report Number
    1030489-2010-00522
    Event Type
    Injury
    Date Received
    April 16, 2010
    Report Date
    March 18, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWQ
    PMA / PMN Number
    UNKNOWN
    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 & 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 30 PATIENTS UNDERWENT ANTERIOR CERVICAL FUSION PROCEDURES USING A CERVICAL PLATING SYSTEM WITH A LEFT-SIDED APPROACH. ALL PATIENTS WERE IMMOBILIZED IN EITHER A HARD COLLAR OF A TWO-POSTER BRACE POSTOPERATIVELY. FIFTEEN PATIENTS REPORTED DYSPHAGIA AT ONE MONTH POST-OP. TWELVE PATIENT'S REPORTED DYSPHAGIA AT 2 MONTHS POST OP. FOUR PATIENTS REPORTED DYSPHAGIA AT 6 MONTHS POST OP. TWO PATIENTS REPORTED DYSPHAGIA AT 12 MONTHS POSTOP. NO PATIENTS REPORTED DYSPHAGIA AT 24 MONTHS POSTOP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK