BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL DURAL SEALANT SYSTEM

    MDR report key: 3031118 · Received July 5, 2006

    Report

    Report Number
    3008196149-2006-00003
    Event Type
    Injury
    Date Received
    July 5, 2006
    Report Date
    June 16, 2006
    Manufacturer
    CONFLUENT SURGICAL, INC.
    Product Code
    NQR
    PMA / PMN Number
    P040034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE SURGEON WHO PERFORMED THE INITIAL PROCEDURE, NOR THE INSTITUTION IN WHICH THE INITIAL PROCEDURE WAS PERFORMED HAVE BEEN IDENTIFIED. THE DURASEAL DURAL SEALANT SYSTEM IS INTENDED FOR USE AS AN ADJUNCT TO SUTURED DURAL REPAIR DURING CRANIAL SURGERY TO PROVIDE WATERTIGHT CLOSURE. THE APPLICATION OF DURASEAL SEALANT IN A SPINE PROCEDURE IS NOT AN APPROVED USE OF THE DEVICE IN THE UNITED STATES. THE IFU PROVIDED WITH DURASEAL SEALANT INCLUDES A CONTRAINDICATION STATING "DO NOT APPLY THE DURASEAL HYDROGEL TO CONFINED BODY STRUCTURES WHERE NERVES ARE PRESENT SINCE NEURAL COMPRESSION MAY RESULT DUE TO HYDROGEL SWELLING. THE HYDROGEL MAY SWELL UP TO 50% OF ITS SIZE IN ANY DIMENSION." THE COMPANY ROUTINELY PROVIDES TRAINING TO FIELD PERSONNEL REINFORCING THE APPROVED INDICATION FOR USE AND THE CONTRAINDICATIONS AND PRECAUTIONS STATED IN THE INSTRUCTIONS FOR USE. THE INVESTIGATION OF THIS EVENT IS ONGOING. REPEATED ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE TO DATE BEEN UNSUCCESSFUL. ANY ADDITIONAL INFORMATION OBTAINED WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE PATIENT DESCRIBED IN THE ALLEGED EVENT, WAS REFERRED TO THE INITIAL REPORTER BY ANOTHER SURGEON WHO HAS NOT BEEN IDENTIFIED. THE INITIAL PROCEDURE WAS REPORTED TO BE AN ANTERIOR CERVICAL DISCECTOMY AND FUSION. DURING THIS SPINAL PROCEDURE IN WHICH A SMALL DURAL TEAR WAS REPORTEDLY CLOSED, DURASEAL SEALANT WAS APPLIED (APPLICATION OF DURASEAL SEALANT IN SPINAL SURGERY IS NOT AN APPROVED INDICATION IN THE UNITED STATES). FOLLOWING APPLICATION OF THE SEALANT MATERIAL, THE DISC SPACE WAS FILLED WITH A BONE GRAFT. A PLATE WAS ADDED OVER THE CONFINED SPACE WHERE THE DURASEAL SEALANT HAD BEEN APPLIED. TWO DAYS AFTER SURGERY, SIGNS OF PARALYSIS WERE REPORTEDLY IDENTIFIED AND THE SURGEON RE-OPERATED TO RELIEVE COMPRESSION OF THE SPINAL CORD. DURING THIS REOPERATION, THE SURGEON REMOVED THE PLATE, BONE GRAFT, AND DURASEAL MATERIAL. THE PATIENT WAS SUBSEQUENTLY REFERRED TO THE INITIAL REPORTER WHO INDICATES THAT THE PATIENT CONTINUES TO SHOW SIGNS OF PARALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURASEAL DURAL SEALANT SYSTEM SURGICAL SEALANT, POLYMERIZING NQR CONFLUENT SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R