BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR PLATE SYSTEM

    MDR report key: 2831947 · Received November 7, 2012

    Report

    Report Number
    MW5027583
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    September 6, 2012
    Report Date
    November 7, 2012
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD ACDF SURGERY ON C5 AND C6. THE ZEPHYR PLATE SYSTEM WAS USED, TWO OF THE FOUR SCREWS ARE ANGLED THROUGH THE VERTEBRA AND INTO THE DISC SPACE BELOW. ALSO THERE IS LORDOSIS DUE TO THE PROCEDURE, NUMBNESS PAIN LOSS OF STRENGTH AND LOSS OF RANGE OF MOTION IN THE NECK. REASON FOR USE: STENOSIS AND BULGING RUPTURE DISC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZEPHIR PLATE SYSTEM ZEPHIR KWQ C1713
    2 ZEPHIR ACDF PLATE KIT ZEPHIR KWQ
    3 ZEPHIR SF DRILL SCREWS 15MM ZEPHIR KWQ

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Disability