BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTELP

    MDR report key: 6529749 · Received April 28, 2017

    Report

    Report Number
    3006982954-2016-00001
    Event Type
    Malfunction
    Date Received
    April 28, 2017
    Date of Event
    February 24, 2016
    Report Date
    March 24, 2016
    Manufacturer
    VGI MEDICAL, LLC
    Product Code
    OVD
    PMA / PMN Number
    K151312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO COMPANY.

    Description of Event or Problem · 1

    POST-OP X-RAY REVEALED A BROKEN SCREW USED TO ACTUATE THE INTEGRATED FIXATION OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312802 VERTELP LATERAL INTERBODY, PRODUCT CODE OVD OVD VGI MEDICAL, LLC VG-LP-18X50X10(7) 131722-004

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention