BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLYDESDALE SPINAL SYSTEM

    MDR report key: 6746381 · Received July 27, 2017

    Report

    Report Number
    1030489-2017-01823
    Event Type
    Injury
    Date Received
    July 27, 2017
    Report Date
    June 28, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: "KEI MIYAMOTO, YUICHI KONDO, KATSUTOKI SIMIZU (GIFU MUNICIPAL HOSPITAL SPINAL CENTRE), HIROSHI NAKAMURA, YUKIHIRO SIRAI, YUSUKE SASAI, TAKATOSHI YAMAMOTO, HISAYUKI AOTO (ORTHOPAEDIC DEPARTMENT, GIFU MUNICIPAL HOSPITAL), ATSUYUKI MORI, HIROMI OTSUKA (PROSTHETIC JOINT CENTRE, GIFU MUNICIPAL HOSPITAL) ", "16 STUDY OF INDICATION, OUTCOMES, COMPLICATIONS AND ISSUE OF XLIF/OLIF IN OUR HOSPITAL" (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. ALTHOUGH IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ABSTRACT THAT TOTAL OF 36 PATIENTS UNDERWENT LUMBAR INTERBODY FUSION (OBLIQUE LUMBAR INTERBODY FUSION/EXTREME LATERAL INTERBODY FUSION). 1 ANTERIOR LONGITUDINAL LIGAMENT INJURY WAS OBSERVED INTRA-OP. IT WAS TREATED BY CONSERVATIVE TREATMENT, AND NO SEQUELAE WERE OBSERVED DURING FOLLOW UP PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527349 CLYDESDALE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other