BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1141359 · Received August 27, 2008

    Report

    Report Number
    2953769-2008-00037
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 5, 2008
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NQO
    PMA / PMN Number
    P04001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FILING OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT ANY DEVICE DISCUSSED HEREIN CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT. DEVICE NOT RETURNED, FOLLOW UP CONVERSATION WITH COMPANY REPRESENTATIVE AND REPORTING PHYSICIAN. 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

    A PATIENT UNDERWENT X-STOP REMOVAL (2 LEVELS) DUE TO CONTINUING PAIN. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON DISCOVERED THE SPINOUS PROCESS FRACTURED AND A LAMINECTOMY WAS PERFORMED. THE PATIENT IS DOING WELL AFTER THE X-STOP REMOVAL AND LAMINECTOMY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R