BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALEO AL

    MDR report key: 4620430 · Received March 18, 2015

    Report

    Report Number
    3005032068-2015-00002
    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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT REMOVED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT DURING SURGERY TO IMPLANT PEDICLE SCREWS, AN ANTERIOR INTERBODY IMPLANT HAD MIGRATED. NO ADD'L SURGERY WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184213 VALEO AL INTERBODY FUSION DEVICE ODP AMEDICA CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK