BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASEAL EXACT SPINE SEALANT SYSTEM 3ML US BOX OF

    MDR report key: 4200024 · Received October 21, 2014

    Report

    Report Number
    3003418325-2014-00009
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 26, 2014
    Manufacturer
    INTEGRA LIFESCIENCES HOLDING CORPORATION
    Product Code
    NQR
    PMA / PMN Number
    P080013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS (SAME PATIENT, SAME SURGERY, SAME PRODUCT ID, SAME LOT NUMBER, DIFFERENT PRODUCT PROBLEM). THIS REPORT IS IN REGARDS TO THE SECOND DURASEAL SEALANT. THE FIRST SYRINGE WAS COMPLETELY EMPTY UPON PUTTING THE DURASEAL ON THE STERILE FIELD FOR A 3 LEVEL DECOMPRESSION WITH STABILIZATION PROCEDURE. IN OBTAINING A SECOND DURASEAL PRODUCT, INCURRED A 20 MINUTES SURGICAL DELAY. THE CUSTOMER WAS UNABLE TO GET THE SECOND DURASEAL UNIT TO MIX. THERE WAS NO PT INJURY. THE SURGEON CLOSED THE DURA WITH SUTURES INSTEAD OF DURASEAL SEALANT. BOTH DURASEAL PRODUCTS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669826 DURASEAL EXACT SPINE SEALANT SYSTEM 3ML US BOX OF DURASEAL SPINE NQR INTEGRA LIFESCIENCES HOLDING CORPORATION N4B0628X

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR