BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1981495 · Received February 8, 2011

    Report

    Report Number
    2953769-2011-00011
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    December 10, 2010
    Report Date
    January 25, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN X-STOP PROCEDURE AT TWO LEVELS L2/L3 AND L3/L4. APPROXIMATELY 15 MONTHS POSTOPERATIVELY, THE DEVICES WERE REMOVED DUE TO ERROSION OF THE SPINOUS PROCESSES AT LEVELS L2/L3 AND L3/L4, AND RECURRENT STENOSIS AT LEVEL L2/L3. LUMBAR LAMINECTOMY WAS PERFORMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. LUMBAR SPINAL STENOSIS SYMPTOMS WERE TREATED. PATIENT'S STATUS IS GOOD. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Other