BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRAIGHT COBB

    MDR report key: 3871227 · Received June 13, 2014

    Report

    Report Number
    1030489-2014-02749
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OBLIQUE LUMBAR INTERBODY FUSION (OLIF) AT L3-L5. AT THE TIME PREPARING L4/5 INTERVERTEBRAL DISK, SOMETHING WHICH WAS NOT INTERVERTEBRAL DISK TISSUE SEEMED TO BE PULLED BY ONE INSTRUMENT. THEREAFTER, AT THE TIME PREPARING THE INTERVERTEBRAL DISK WITH THE A DIFFERENT INSTRUMENT, ABDOMINAL-SIDE DURA MATER WAS DAMAGED DUE TO AN APPROACH FROM SPINAL CANAL SIDE. CAGES WERE SUBSEQUENTLY PLACED FROM ANTERIOR AND THE INCISION WAS CLOSED. IT WAS CONFIRMED ON A MICROSCOPE IMAGE FROM A POSTERIOR VIEW THAT THERE WAS A SPINAL FLUID LEAK AROUND THE CONCERNED DURA MATER WHICH SEEMED TO BE SHRUNK COMPARING WITH THAT AT L3/4. FRAGMENT(S) ASSUMED TO BE A PART OF NERVE STRUCTURES WERE ALSO CONFIRMED. L4 AND L5 NERVE ROOTS WERE VISIBLY CONFIRMED. A DAMAGE OF DURA MATER WAS SEEN ON THE VENTROLATERAL SIDE. ARTIFICIAL DURA MATER WAS REPORTEDLY PLACED. THEREAFTER, A POSTERIOR FUSION WAS CONDUCTED. THE SURGICAL TIME WAS EXTENDED DUE TO THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350871 STRAIGHT COBB ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA NM12A003

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR