BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF 5

    MDR report key: 5050568 · Received September 2, 2015

    Report

    Report Number
    3003418325-2015-00015
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Report Date
    August 6, 2015
    Manufacturer
    INTEGRA LIFESCIENCES HOLDING CORP
    Product Code
    NQR
    PMA / PMN Number
    P080013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 10/30/2015. THE INVESTIGATION INCLUDED: METHODS: REVIEW OF DEVICE HISTORY REVIEW OF COMPLAINTS HISTORY RESULTS: A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN PERFORMED. THIS REVIEW CONFIRMED THAT THIS LOT OF PRODUCTS WAS REVIEWED AND RELEASED ACCORDING TO QA SPECIFICATIONS. A REVIEW OF HISTORICAL COMPLAINT DATA DISPLAYED NO INCREASE IN TRENDS. CONCLUSION: THE CLINICALLY APPLIED PRODUCT WAS NOT RETURNED TO US FOR EVALUATION; THEREFORE, WE ARE UNABLE TO IDENTIFY THE SPECIFIC CAUSE FOR THE PROBLEM REPORTED. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT OUR PRODUCTS ARE RELEASED MEETING ALL CURRENT SPECIFICATIONS. ALTHOUGH A SPECIFIC ROOT CAUSE ANALYSIS COULD NOT BE PERFORMED, THE INCIDENT IS MAINTAINED IN OUR DATABASE FOR A BROADER TREND ANALYSIS. IF ADDITIONAL INFORMATION IS OBTAINED, OR THE SAMPLE IS RETURNED, WE WILL RE-OPEN THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS USING THE PRODUCT DURING A CASE AND IT WAS FOUND THAT 2 OUT OF 5 OF THE DURASEALS HAD GELLED INSIDE THE PACKAGE; SUSPECT OVERHEATED IN PACKAGE. THERE WAS NO PATIENT CONTACT BUT THE PATIENT WAS PREPPED FOR SURGERY. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583321 DURASEAL EXACT SPINE SEALANT SYSTEM 5ML US BOX OF 5 DURASEAL SPINE NQR INTEGRA LIFESCIENCES HOLDING CORP N5C1508X

    Patients

    Seq Age Sex Outcome Treatment
    1