BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-PAL SMALL TEST IMPLANT

    MDR report key: 2070401 · Received April 19, 2011

    Report

    Report Number
    8030965-2011-00201
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 2, 2011
    Report Date
    April 11, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    MAX
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE NOT EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    A DEVICE REPORT RECEIVED FROM WALDENBURG INDICATES: DURING A CLICK-X PROCEDURE IN (B)(6): SURGEON INSERTED THE T-PAL SMALL TEST IMPLANT, WHEN THE SURGEON WENT TO REMOVE WITH THE ORACLE SLIDE HAMMER HE WAS UNSUCCESSFUL. SURGEON NOTED THAT DUE TO THE L5/S1 LEVEL AND ANATOMY OF THE PT THE DISC SPACE WAS VERY NARROW. SURGEON THEN USED A REMOVAL TOOL AND WAS ALSO UNSUCCESSFUL. SURGEON DECIDED TO IMPLANT THE SMALL TRIAL IMPLANT AND FILLED THE DISC SPACE WITH CHRONOS AND AUTOGRAFT COMPLETING THE PROCEDURE. A FEW WEEKS LATER AN X-RAY WAS TAKEN AND SHOWED THE IMPLANT IN A GOOD POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T-PAL SMALL TEST IMPLANT T-PAL SMALL TEST IMPLANT MAX SYNTHES GMBH NA 3422013

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention CHRONOS| AUTOGRAFT