BEUDAMED
    FDA Adverse Event Other Summary report: N

    X STOP IPD SYSTEM

    MDR report key: 744612 · Received July 31, 2006

    Report

    Report Number
    2953720-2006-00003
    Event Type
    Other
    Date Received
    July 31, 2006
    Date of Event
    July 6, 2006
    Report Date
    July 31, 2006
    Manufacturer
    ST. FRANCIS MEDICAL TECHNOLOGIES, INC.
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: NO CONCLUSION CAN BE DRAWN. THE DEVICE HAS BEEN RETURNED TO THE COMPANY, BUT THE INVESTIGATION RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS WRITING. NO CONCLUSION CAN BE MADE AT THIS TIME. AS SURGICAL INTERVENTION OCCURRED, AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.

    Description of Event or Problem · 1

    AN X STOP INTERSPINOUS DECOMPRESSION SPINAL IMPLANT WAS INSERTED. TWO WEEKS POST-OPERATIVELY , AN X-RAY IDENTIFIED A COMPONENT DETACHMENT FROM THE MAIN IMPLANT BODY. THE MAIN IMPLANT BODY WAS STILL IN PLACE AND THE PT WAS ASYMPTOMATIC. A SECOND PROCEDURE WAS PERFORMED AND THE IMPLANT WAS REPLACED WITH A LARGER SIZE X STOP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X STOP IPD SYSTEM INTERSPINOUS PROCESS PROSTHESIS NQO ST. FRANCIS MEDICAL TECHNOLOGIES, INC. NA 060110

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention