BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALEO PL

    MDR report key: 2116449 · Received June 1, 2011

    Report

    Report Number
    3005032068-2011-00002
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 13, 2009
    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

    TWO VALEO PL SPACERS WERE REVISED AND REMOVED DUE SUBSIDENCE OF THE IMPLANT. THE REVISION WENT FINE AND THE SURGEON WAS HAPPY WITH THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALEO PL VERTEBRAL BODY REPLACEMENT MQP AMEDICA CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R