BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZAVATION, LLC

    MDR report key: 6665335 · Received June 23, 2017

    Report

    Report Number
    3008583793-2017-00003
    Event Type
    Malfunction
    Date Received
    June 23, 2017
    Manufacturer
    ZAVATION, LLC
    Product Code
    KWQ
    UDI-DI
    00842166105607
    PMA / PMN Number
    K112533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    COMPLAINT DESCRIPTION - TAB BROKE FROM LOCKING CAM WHICH ALLOWED SCREW TO BACK OUT. SURGEON ELECTED TO REMOVE SCREW AS FUSION WAS SOLID. REVISION SURGERY WAS COMPLETED WITH NO KNOWN COMPLICATIONS. SURGEON ELECTED TO REMOVE ONLY THE 1 SCREW AS FUSION WAS SOLID. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446034 ZAVATION, LLC 4-LEVEL CERVICAL PLATE KWQ ZAVATION, LLC 30-0460 Z0404 00842166105607

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention