BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZAVATION CERVICAL PLATE SYSTEM

    MDR report key: 6757788 · Received August 1, 2017

    Report

    Report Number
    3008583793-2017-00006
    Event Type
    Malfunction
    Date Received
    August 1, 2017
    Report Date
    August 1, 2017
    Manufacturer
    ZAVATION MEDICAL PRODUCTS LLC
    Product Code
    KWP
    PMA / PMN Number
    K112484
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PHOTOS OF X RAYS RECEIVED BY ZAVATION IDENTIFY THAT THE SCREW HAD WORKED ITSELF OUT OF THE PLATE AND DISLODGED. A REVIEW OF THE PAST DHR'S (DEVICE HISTORY RECORD) REVEALED NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536490 ZAVATION CERVICAL PLATE SYSTEM CERVICAL PLATE CERVICAL SCREW KWP ZAVATION MEDICAL PRODUCTS LLC 30-01XX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other