BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZAVATION

    MDR report key: 6179267 · Received December 15, 2016

    Report

    Report Number
    3008583793-2016-00001
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 11, 2016
    Report Date
    December 8, 2016
    Manufacturer
    ZAVATION, LLC
    Product Code
    KWQ
    PMA / PMN Number
    K112533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 1-LEVEL CERVICAL PLATE LOCKING MECHANISM WAS LOOSE AND ROTATING FREELY. THE PLATE WAS NOT EXPLANTED. NOTE: LIMITED DETAILS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830184 ZAVATION CERVICAL PLATE KWQ ZAVATION, LLC 30-0114

    Patients

    Seq Age Sex Outcome Treatment
    1