BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALEO TL

    MDR report key: 3948805 · Received May 2, 2014

    Report

    Report Number
    3005032068-2014-00002
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    April 8, 2014
    Report Date
    May 2, 2014
    Manufacturer
    AMEDICA CORP.
    Product Code
    MAX
    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 NOT RETURNED TO AMEDICA FOR EVAL. THE DEVICE IN QUESTION WAS IMPLANTED AS PART OF A 4-LEVEL PROCEDURE. THE 11MM IMPLANT WAS SUBSEQUENTLY REVISED AFTER IT PARTIALLY EXPULSED FROM THE OPERATIVE SITE 10 DAYS POST OP. IT WAS REPLACED BY A 17MM IMPLANT. THIS SUGGESTS THAT THE INITIAL IMPLANT WAS UNDERSIZED FOR THE IMPLANT SITE. ADDITIONALLY, THE PT WAS REPORTED AS BEING A SMOKER.

    Description of Event or Problem · 1

    DOCTOR REPORTED A L4-L5 TL IMPLANT EXPULSED. INITIAL CASE WAS A 4-LEVEL TL ON (B)(6) 2014. REVISION PERFORMED ON (B)(6) 2014. THE DOCTOR REPLACED THE 11MM TIL WITH A 17MM TL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265638 VALEO TL INTERBODY FUSION DEVICE MAX AMEDICA CORP. NA 901708

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention