BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-STOP INTERSPINOUS SPACER SYSTEM

    MDR report key: 6577660 · Received May 19, 2017

    Report

    Report Number
    1030489-2017-01265
    Event Type
    Injury
    Date Received
    May 19, 2017
    Report Date
    April 25, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: TOMOYA MUTA, SADANOBU KATSUBE , EIJI IWASAKI "SHORT TERM RESULTS OF LUMBAR STABILIZATION (X-STOP) FOR LUMBAR SPINAL STENOSIS" MEAN AGE 73.8 YEARS; 31 MALE, 19 FEMALE. (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.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE ABSTRACT THAT AMONG 70 LUMBAR STENOTIC PATIENTS UNDERGOING SPINE SURGERY FROM (B)(6) 2012 - (B)(6) 2015, 60 PATIENTS WHO WERE FOLLOWED UP FOR MORE THAN 12 MONTHS WERE INVESTIGATED IN THE STUDY. AS POSTOPERATIVELY 7 PATIENT REPORTED REVISION SURGERY DUE TO INTERMITTENT CLAUDICATION RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359896 X-STOP INTERSPINOUS SPACER SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other| R