BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALEO PL SYSTEM

    MDR report key: 3165001 · Received June 5, 2013

    Report

    Report Number
    3005032068-2013-00001
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 7, 2013
    Report Date
    June 5, 2013
    Manufacturer
    AMEDICA CORP.
    Product Code
    MAX
    PMA / PMN Number
    K091278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DR WAS USING THE VALEO PL SYSTEM AND WAS IN THE PROCESS OF SELECTING A TRIAL TO DETERMINE THE APPROPRIATE IMPLANT HEIGHT WHEN THE INNER SHAFT OF THE T-HANDLE ON THE MODULAR TRIAL INSTRUMENT BROKEN AT THE THREADED ROD-MODULAR TRIAL INTERFACE. THE TRIAL WAS WEDGED INTO THE DISC SPACE AND THE DR HAD DIFFICULTY IN REMOVING IT. HE USED A MIDAS REX TO REMOVE THE TRIAL. THERE WAS A DELAY OF SURGERY. THE DR PACKED THE SPACE WITH BONE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249611 VALEO PL SYSTEM MODULAR TRIAL MAX AMEDICA CORP. 55Z06

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention