BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5

    MDR report key: 14434949 · Received May 19, 2022

    Report

    Report Number
    1121308-2022-00034
    Event Type
    Injury
    Date Received
    May 19, 2022
    Date of Event
    March 22, 2022
    Report Date
    July 18, 2022
    Manufacturer
    INTEGRA - PRINCETON
    Product Code
    NQR
    PMA / PMN Number
    P040034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 (202050) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE, AS SUCH ONLY A DHR REVIEW COULD BE PERFORMED: DEVICE HISTORY RECORD (DHR) REVIEW - AT THE TIME OF MANUFACTURING RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS. FAILURE ANALYSIS & ROOT CAUSE - THE ROOT CAUSE IS UNDETERMINED AND WAS UNABLE TO BE CONFIRMED IN THE COMPLAINT EVALUATION. A DHR REVIEW AND TRENDING WERE PERFORMED AS PART OF THE EVALUATION. PROPER FINISHED GOOD TESTING WAS PERFORMED PRIOR TO RELEASE AS INDICATED IN THE DHR. PRODUCT WAS NOT RECEIVED FOR ANALYSIS AND THE INVESTIGATION COULD NOT CONFIRM THE COMPLAINT. MEDICAL ASSESSMENT - A MEDICAL ASSESSMENT WAS PERFORMED BY INTEGRA MEDICAL AFFAIRS AND CONCLUDED THAT THERE IS INSUFFICIENT EVIDENCE TO SUGGEST THAT THE PRODUCT WAS CAUSAL TO THE REPORTED EVENTS, AS IT APPEARS TO BE PROCEDURALLY RELATED. AS PER PRODUCT INSERT, INFECTION IS AN OBSERVED ADVERSE EVENT. HOWEVER, PER COMPLAINT, THE SURGEON HAD REPORTS OF INFECTION ON THREE DIFFERENT PATIENTS POST-OPERATIVELY, EACH ONE WITH A DIFFERENT ORGANISM. ALL PATIENTS WERE TREATED WITH MEDICAL AND/OR SURGICAL INTERVENTION. THE RISK REMAINS ACCEPTABLE PER THE RISK ANALYSIS. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    THIS REPORT IS FOR "PATIENT B" REPRESENTING 2 OF 3 REPORTS, AND LINKED TO MFG REPORT NUMBERS: 1121308-2022-00033 AND 1121308-2022-00035. A FACILITY REPORTED THAT THE DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 (202050) WAS USED IN A LAMINECTOMY CASE, AND 3 CONSECUTIVE INFECTIONS OCCURRED. "PATIENT B" DEVELOPED A DEEP INCISIONAL PRIMARY (DIP) SURGICAL SITE INFECTION 8 DAYS POSTOPERATIVELY. PATIENT B WAS RETURNED TO SURGERY ON (B)(6) 2022 AND AGAIN ON (B)(6) 2022 FOR EXPLORATION OF THORACIC WOUND WITH WASHOUT WITH 2000 ML OF ANCEF AND REMOVAL OF RESIDUAL DURASEAL. WOULD CULTURE WAS OBTAINED AND WAS POSITIVE FOR S. VIRIDANS FROM THE DEEP INCISIONAL SITE. INFECTIOUS DISEASE CONSULT WAS OBTAINED AND PATIENT TREATED WITH VANCOMYCIN, ANCEF, AND ROCEPHIN. PATIENT B HAS BEEN DISCHARGED HOME WITH IV ANTIBIOTICS. NO SURGICAL DELAY HAS BEEN REPORTED. THE FACILITY IS INVESTIGATING TO DETERMINE WHERE THE INFECTION SOURCE IS COMING FROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975871 DURASEAL DURAL SEALANT SYSTEM 5ML US BOX OF 5 DURASEAL CRANIAL NQR INTEGRA - PRINCETON 60355188

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female