BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALEO C

    MDR report key: 4620429 · Received March 18, 2015

    Report

    Report Number
    3005032068-2015-00004
    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

    Description of Event or Problem · 1

    SURGEON REPORTED THAT A VALEO C CERVICAL IMPLANT HAD SUBSIDED AND HE PERFORMED A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183102 VALEO C INTERBODY FUSION DEVICE ODP AMEDICA CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK