BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 4394142 · Received January 7, 2015

    Report

    Report Number
    1030489-2015-00059
    Event Type
    Injury
    Date Received
    January 7, 2015
    Date of Event
    August 1, 2013
    Report Date
    December 9, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: NADER S. DAHDALEH, M.DM; ET AL. ¿OUTCOME FOLLOWING UNILATERAL VERSUS BILATERAL INSTRUMENTATION IN PATIENTS UNDERGOING MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION: A SINGLE-CENTER RANDOMIZED PROSPECTIVE STUDY¿. NEUROSURG FOCUS 35 (2):E13, 2013. (B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE TITLED ¿OUTCOME FOLLOWING UNILATERAL VERSUS BILATERAL INSTRUMENTATION IN PATIENTS UNDERGOING MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION: A SINGLE-CENTER RANDOMIZED PROSPECTIVE STUDY¿ THAT FORTY-ONE PATIENTS WERE RANDOMLY ASSIGNED TO RECEIVE EITHER BILATERAL OR UNILATERAL INSTRUMENTATION FOLLOWING 1 LEVEL UNILATERAL MIS-TLIF. FOUR PATIENTS WERE LOST TO FOLLOW UP IN THE UNILATERAL GROUP AND ONE PATIENT WAS LOST TO FOLLOW UP IN THE BILATERAL GROUP. ONE PATIENT FROM THE UNILATERAL GROUP WAS REPORTED TO SUFFER POST-OPERATIVE PULMONARY EDEMA AND WAS HOSPITALIZED FOR EIGHT DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14215 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R