BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALEO AL

    MDR report key: 2137360 · Received May 28, 2011

    Report

    Report Number
    3005032068-2011-00008
    Event Type
    Injury
    Date Received
    May 28, 2011
    Date of Event
    February 22, 2011
    Report Date
    May 27, 2011
    Manufacturer
    AMEDICA CORP.
    Product Code
    MQP
    PMA / PMN Number
    K073505
    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 PT HAD RETURNED FOR A F/U EXAM AND THE DR NOTED THAT THE IMPLANT (VALEO AL) HAD MIGRATED PARTIALLY OUT OF THE DISC SPACE. AT THAT TIME, A REVISION SURGERY WAS NOT PLANNED, F/U WOULD OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALEO AL INTERVERTEBRAL BODY FUSION MQP AMEDICA CORP. 900609

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R