BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1873515 · Received September 22, 2010

    Report

    Report Number
    2953769-2010-00403
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MEDTRONIC SPINE, LLC
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "THE USE OF X-STOP IN THE MANAGEMENT OF RADICULOPATHY IN SPONDYLOLISTHESIS", BY MARYGRACE C. HAGAN MD, JENNIFER ROGER, ERIC P. ROGER, BSC, FRCS (C). METHOD: DEVICE NOT RETURNED; F/U WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "THE USE OF X-STOP IN THE MANAGEMENT OF RADICULOPATHY IN SPONDYLOLISTHESIS", THE FOLLOWING WAS REPORTED: DURING THE STUDY PERIOD, TWENTY PTS PRESENTING WITH SPONDYLOLISTHESIS WERE TREATED WITH X-STOP. DEVICE MIGRATION WITH RECURRENCE OF SYMPTOMS OCCURRED IN FOUR (20%) PTS AT A MEAN F/U OF EIGHTEEN (RANGE (6-28) MONTHS. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR