BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP INTERSPINOUS SPACER SYSTEM

    MDR report key: 4919809 · Received July 16, 2015

    Report

    Report Number
    1030489-2015-01485
    Event Type
    Injury
    Date Received
    July 16, 2015
    Report Date
    June 17, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NQO
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: SEI TOMINAGA "LUMBAR CANAL STENOSIS SURGERY BY X-STOP PEEK". (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 ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A SURGERY WITH GENERAL ANESTHESIA ON DECUBITUS POSITION. DURING THE SURGERY, THE PATIENT'S SPINOUS PROCESS BROKE DUE TO OSTEOPOROSIS AND THEREFORE THE APPROACH WAS CHANGED TO LAMINOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461360 X-STOP INTERSPINOUS SPACER SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Other