BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP®PEEK INTERSPINOUS SPACER

    MDR report key: 4894027 · Received July 7, 2015

    Report

    Report Number
    1030489-2015-01384
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    May 1, 2014
    Report Date
    June 4, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS IMPLANTED INTERSPINOUS PROCESS SPACER AT L4-L5 TO TREAT LUMBAR CANAL STENOSIS. THE PATIENT'S SYMPTOM WAS ONCE IMPROVED. ON A MONTH AFTER POST-OP, THE PATIENT DEVELOPED L3-L4 LUMBAR CANAL STENOSIS. DECOMPRESSION WAS PERFORMED. ON A YEAR POST-OP, THE PATIENT DEVELOPED L4-L5 SYMPTOM AGAIN. REVISION WAS PERFORMED FOR DECOMPRESSION AND FOR REMOVAL OF THE INTERSPINOUS PROCESS SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440952 X-STOP®PEEK INTERSPINOUS SPACER PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention