BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL SEALANT SYSTEM 5ML, OUS

    MDR report key: 1593599 · Received February 1, 2010

    Report

    Report Number
    3003157248-2010-00002
    Event Type
    Injury
    Date Received
    February 1, 2010
    Report Date
    January 18, 2010
    Manufacturer
    CONFLUENT SURGICAL, INC
    Product Code
    NQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SWELLING OF THE DURASEAL IS A NORMAL CONDITION. THE CURRENT DURASEAL IFU FOR DSD5005, ITEM LCN 80-2005-159 REV A, LISTS THE FOLLOWING WARNING: "DO NOT USE THE DURASEAL SURGICAL SEALANT AS A VOID FILLER IN THE SPINE, AS POST-OPERATIVE HYDROGEL SWELLING MAY IMPINGE ON SURROUNDING TISSUES. THE SURGICAL SEALANT MAY SWELL UP TO 50% OF ITS SIZE IN ANY DIRECTION." THE PREVIOUS DURASEAL IFU FOR DSD5005, ITEM LCN 80-2005-072 REV H, LISTED THE SAME WARNING: "DO NOT USE THE DURASEAL SURGICAL SEALANT AS A VOID FILLER IN THE SPINE, AS POST-OPERATIVE HYDROGEL SWELLING MAY IMPINGE ON SURROUNDING TISSUES. THE SURGICAL SEALANT MAY SWELL UP TO 50% OF ITS SIZE IN ANY DIRECTION."

    Description of Event or Problem · 1

    ACCORDING TO A PUBLISHED ARTICLE IN THE JOURNAL SPINE, VOLUME 35, NO. 1, THERE IS A CASE REPORT OF A SUBJECT WHO UNDERWENT A C5-C6 ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH A STANDARD COMMERCIAL PEEK SPACE CAGE. INTRAOPERATIVELY, THERE WAS A SMALL CSF LEAK WHEN EXCISING THE POSTERIOR LONGITUDINAL LIGAMENT. SURGICEL AND DURASEAL WERE USED TO SEAL THE LEAK, AND THE AREA WAS DRY BEFORE CAGE INSERTION. THREE HOURS AFTER SURGERY THE PATIENT EXPERIENCED WEAKNESS TO HIS UPPER AND LOWER LIMBS. AN MRI SCAN DEMONSTRATED CERVICAL CORD COMPRESSION DUE TO THE EXPANSION OF DURASEAL. THE PATIENT WAS TAKEN TO THEATER FOR EMERGENCY EXPLORATION AND DECOMPRESSION, AT WHICH POINT THE DURASEAL WAS NOTED TO BE EXPANDED AND WAS REMOVED. ALSO REMOVED WAS THE MINIMAL AMOUNT OF SURGICEL, WHICH WAS SEPARATE AND NOT INTERFERING WITH THE DURASEAL. AFTER SURGERY THE PATIENT IS SHOWING RAPID IMPROVEMENT WITH HIS POWER INCREASING TO ALL 4 LIMBS, UPPER (4/5), AND LOWER (3/5) BILATERALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURASEAL SEALANT SYSTEM 5ML, OUS DURAL SEALANT NQR NQR CONFLUENT SURGICAL, INC NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention