BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1122883 · Received August 14, 2008

    Report

    Report Number
    2953769-2008-00032
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 16, 2008
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP WITH REPORTING INVESTIGATOR SITE. THE FILING OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT ANY DEVICE DISCUSSED HEREIN CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A CLINICAL STUDY THAT DURING AN X-STOP PROCEDURE AT L3-L4, THE TREATING SURGEON NOTED THAT THE IMPLANT AT L4-L5 WAS PARTIALLY IN THE WAY. THE TREATING SURGEON WAS ABLE TO IMPLANT THE DEVICE AT L3-L4. THE SURGEON REPORTEDLY NOTED THAT THE TIP OF THE SPINOUS PROCESS AT L3 WAS FRACTURED. THE PT WAS REPORTED TO BE ASYMPTOMATIC AND NO TREATMENT WAS RENDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-STOP IPD SYSTEM INTERSPINOUS PROCESS SPACER NQO MEDTRONIC SPINE LLC. 10MM X-STOP PK 2087051

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other