BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1896971 · Received November 11, 2010

    Report

    Report Number
    2953769-2010-00577
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE UNKNOWN. METHOD - FOLLOW-UP WITH PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN X-STOP PROCEDURE 3 YEARS AGO. THE PROCEDURE DID NOT WORK FOR HER. SHE HAD THREE BACK SURGERIES SINCE, AND HAD AN INFECTION AFTER THE LAST SURGERY. PATIENT IS STILL IN A LOT OF PAIN. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-STOP IPD SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SPINE LLC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other