BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALEO TL

    MDR report key: 4620439 · Received March 18, 2015

    Report

    Report Number
    3005032068-2015-00003
    Event Type
    Malfunction
    Date Received
    March 18, 2015
    Date of Event
    May 9, 2012
    Report Date
    March 17, 2015
    Manufacturer
    AMEDICA CORP.
    Product Code
    ODP
    PMA / PMN Number
    K091278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT REMOVED.

    Description of Event or Problem · 1

    SURGEON NOTICED POST-OP THAT THE IMPLANT WAS ON ITS SIDE. THE IMPLANT WAS LEFT IN THAT POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184215 VALEO TL INTERBODY FUSION DEVICE ODP AMEDICA CORP. NA 900334

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK