BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALEO AL

    MDR report key: 2144035 · Received June 1, 2011

    Report

    Report Number
    3005032068-2011-00006
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    September 7, 2010
    Report Date
    May 27, 2011
    Manufacturer
    AMEDICA CORP.
    Product Code
    MQP
    PMA / PMN Number
    K091278
    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

    AMEDICA WAS CONTACTED BY THE SURGEON, REGARDING A SIX WEEK POST-OP EXAMINATION OF A PATIENT WHO HAD RECEIVED A VALEO AL DEVICE. IMAGES WHICH INCLUDED PRE-OP X-RAY, IMMEDIATE POST-OP X-RAY, SIX WEEK POST-OP X-RAY, AND SIX WEEK POST-OP CT. THE IMAGES REVEALED THAT THE VALEO AL DEVICE HAD PARTIALLY EXPULSED FROM THE DISC SPACE. THE SURGEON STATED THAT HE BELIEVED THE EXPULSION WAS NOT ATTRIBUTED TO THE DEVICE. THE SURGEON CONSULTED ANOTHER SURGEON THAT PRACTICES AT THE SAME HOSPITAL. THE SURGEON DECIDED TO CLOSELY MONITOR THE PATIENT, BUT NOT TO TAKE ANY FURTHER SURGICAL INTERVENTION AT THIS TIME. THE SURGEON STATED THAT THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALEO AL INTERVERTEBRAL BODY FUSION MQP AMEDICA CORP. 900618

    Patients

    Seq Age Sex Outcome Treatment
    1