BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALEO OL

    MDR report key: 2116456 · Received June 1, 2011

    Report

    Report Number
    3005032068-2011-00005
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    January 13, 2010
    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

    PER THE SURGEON, A REVISION WAS REQUIRED BECAUSE THE OL SPACER HAD MIGRATED OUT OF THE DISC SPACE AND WAS IN CONTACT/RUBBING AGAINST THE PEDICLE SCREW. THE SURGEON REMOVED THE OL SPACER AND DIDN'T REPLACE IT WITH ANOTHER IMPLANT, BELIEVING THE PEDICLE SCREW CONSTRUCT WAS SUFFICIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALEO OL VERTEBRAL BODY REPLACEMENT MQP AMEDICA CORP. 900543

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R