BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DURASEAL PRODUCT

    MDR report key: 3397221 · Received October 2, 2013

    Report

    Report Number
    1219930-2013-00843
    Event Type
    Injury
    Date Received
    October 2, 2013
    Report Date
    September 12, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    NQR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTED IN THE JOURNAL OF CLINICAL ORTHOPAEDICS AND RELATED RESEARCH (2012) 470:1640-1645, A PUBLICATION OF THE ASSOCIATION OF BONE AND JOINT SURGEONS. AN ARTICLE TITLED CAUDA EQUINA SYNDROME AFTER A TLIF RESULTING FROM POSTOPERATIVE EXPANSION OF A HYDROGEL DURAL SEALANT. ONE PATIENT WAS IDENTIFIED IN THIS ARTICLE, A 57 YEAR OLD WOMAN HAD A REVISION OF A RIGHT SIDED DISCECTOMY AND TLIF PROCEDURE WITH THE USE OF AN INTERBODY CAGE AND POSTERIOR INSTRUMENTATION WAS PERFORMED. DURING THE DISSECTION THROUGH THE PRIOR SURGERY SITE, A SMALL DURAL TEAR WAS ENCOUNTERED AND REPAIRED, AND 2.5 CC OF DURASEAL WAS APPLIED. ON POSTOP DAY 3, THE PATIENT REPORTED INCREASED BURNING AND PARASTHESIAS IN THE SADDLE REGION. AN MRI REVEALED A CSF LEAK. PATIENT WAS RE-OPERATED FOR EXPLORATION AND DECOMPRESSION OF THE THECAL SAC. IT WAS CONCLUDED THAT THE DURASEAL EXPANDED CAUSING THE COMPRESSION. A LARGE AMOUNT OF THE DURASEAL WAS REMOVED, AND PATIENT EXPERIENCED RESOLUTION OF BURNING AND PARESTHESIAS UPON AWAKENING FROM ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498110 UNKNOWN DURASEAL PRODUCT DURASEAL SEALENT NQR COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other