BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1841529 · Received September 14, 2010

    Report

    Report Number
    2953769-2010-00391
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 27, 2010
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "DYNAMIC STABILIZATION USING X-STOP VS. TRANS-PEDICULAR SCREW FIXATION IN THE TREATMENT OF LUMBAR CANAL STENOSIS: COMPARATIVE STUDY OF THE CLINICAL OUTCOME", BY YOUSSRY ELHAWARY, MD, ALAA AZZAZI, MD. METHOD; DEVICE NOT RETURNED; FOLLOWED UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ABSTRACT TITLED "DYNAMIC STABILIZATION USING X-STOP VS. TRANS-PEDICULAR SCREW FIXATION IN THE TREATMENT OF LUMBAR CANAL STENOSIS: COMPARATIVE STUDY OF THE CLINICAL OUTCOME", THE FOLLOWING EVENT WAS REPORTED: ONE CASE OF DEVICE FAILURE REQUIRING REMOVAL. 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 NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other