BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALEO AL

    MDR report key: 2144023 · Received June 1, 2011

    Report

    Report Number
    3005032068-2011-00007
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    January 10, 2011
    Report Date
    May 27, 2011
    Manufacturer
    AMEDICA CORP.
    Product Code
    MQP
    PMA / PMN Number
    K091278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT REPORTED BY REQUEST OF FDA.

    Description of Event or Problem · 1

    THE SURGEON COMMUNICATED THAT A PATIENT RETURNED FOR FOLLOW UP AND THE IMPLANT (VALEO AL) HAD MIGRATED ANTERIORLY. THE PATIENT WAS ASYMPTOMATIC, AND THE SURGEON IS MONITORING THE PATIENT, BUT IT APPEARS THE IMPLANT IS FUSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALEO AL INTERVERTEBRAL BODY FUSION MQP AMEDICA CORP. 900618

    Patients

    Seq Age Sex Outcome Treatment
    1