BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRESCENT SPINAL SYSTEM

    MDR report key: 1756912 · Received July 2, 2010

    Report

    Report Number
    1030489-2010-00884
    Event Type
    Other
    Date Received
    July 2, 2010
    Date of Event
    June 3, 2010
    Report Date
    June 4, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 9393610, 510K # K094025 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPACTION OF THE INTERBODY DEVICE INTO THE INTRADISCAL SPACE, THE DEVICE BROKE INTO THREE PARTS. THE INTRADISCAL SPACE WAS NOT VERY NARROW AND THE SURGEON TAPPED THE INSERTER WITH LESS FORCE. ONE PORTION OF THE BROKEN CAGE COULD NOT BE REMOVED, AND REMAINED IN THE PT'S DISC SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRESCENT SPINAL SYSTEM INTERBODY DEVICE KWQ MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other