BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1915318 · Received November 2, 2010

    Report

    Report Number
    2953769-2010-00570
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    July 16, 2010
    Report Date
    October 22, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: REVIEW TITLED "APPLICATION OF X STOP DEVICE IN THE TREATMENT OF LUMBAR SPINAL STENOSIS", BY XIAOBIN YI, MD AND BRADLEY MCPHERSON, MD. METHOD: DEVICE NOT RETURNED, FOLLOWED UP WITH AUTHOR. REF: 2953769-2010-00571.

    Description of Event or Problem · 1

    IN A REVIEW TITLED "APPLICATION OF X STOP DEVICE IN THE TREATMENT OF LUMBAR SPINAL STENOSIS", THE FOLLOWING WAS REPORTED: IMPLANT DISLODGEMENT AFTER A FALL. NO ADDITIONAL INFO 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 NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK