BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZAVATION

    MDR report key: 6461580 · Received April 5, 2017

    Report

    Report Number
    3008583793-2017-00001
    Event Type
    Malfunction
    Date Received
    April 5, 2017
    Report Date
    March 8, 2017
    Manufacturer
    ZAVATION, LLC
    Product Code
    KWQ
    UDI-DI
    00842166105300
    PMA / PMN Number
    K112533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    LOCKING PLATE SPUN WHILE TRYING TO LOK SCREW IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244102 ZAVATION CERVICAL PLATE - 1 LEVEL KWQ ZAVATION, LLC 30-0112 00842166105300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other