BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURAGEN PLUS DURAL REGENERATION MATRIX 1X3 1 PAC

    MDR report key: 6720195 · Received July 17, 2017

    Report

    Report Number
    1121308-2017-00011
    Event Type
    Malfunction
    Date Received
    July 17, 2017
    Date of Event
    June 7, 2017
    Report Date
    June 23, 2017
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GXQ
    PMA / PMN Number
    K092388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 8/3/2017. THE DEVICE WAS NOT RETURNED FOR EVALUATION. AS PER COMPLAINT, IT WAS IMPLANTED. DEVICE HISTORY RECORD REVIEW: DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 1140925 WAS REVIEWED. LOT NUMBER: 1140925, CATALOG NUMBER: DP-1013, MANUFACTURING (PACKAGING) DATE: MARCH 24, 2014, EXPIRATION DATE: MARCH 31, 2017. THE MANUFACTURING AND FINAL PACK PROCESSES RAN NORMALLY; NO ANOMALIES WERE FOUND DURING MANUFACTURING PROCESS OF THE PRODUCT. ALL LABELS INCLUDED IN THE SHOP ORDER HAD THE CORRECT EXPIRATION DATE. REVIEW OF PRODUCT'S NCR, AND CAPA HISTORY FROM JUNE 2015 ¿ JUNE 2017: NO RELATED NCR OR CAPA WAS FOUND TO HAVE BEEN OPENED DURING THE PERIOD OF JUNE 2015 TO JUNE 2017. UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM JUNE 2015 TO JUNE 2017, THERE ARE THREE (3) DURAL REPAIR PRODUCT FAMILY COMPLAINTS (INCLUDING THE ONE UNDER EVALUATION) RELATED TO THE USE OF EXPIRED PRODUCT. THE COMPLAINT OCCURRENCE RATE FOR THIS TYPE OF INCIDENT IS THEN 0.00056%. NO UNUSUAL EVENT RELATED TO THE REPORTED FAILURE WAS NOTICED DURING THE LOT RECORDS REVIEW. AS PART OF MANUFACTURING/PACKAGING DOCUMENTATION, SAMPLES OF PRINTED MATERIAL ARE ATTACHED TO THE DHR AND ALL SHOWED THE CORRECT EXPIRATION DATE (SAME AS REPORTED BY THE CUSTOMER: 03-2017). THE LAST SHIPMENT OF LOT 1140925 TO TRAVIS AIR FORCE BASE WAS COMPLETED BY SEPTEMBER 2014. THE CUSTOMER IS NOT ACTUALLY QUESTIONING THE PRODUCT OR EXPIRATION DATE; INSTEAD, THE CUSTOMER IS ASKING REGARDING POSSIBLE CONSEQUENCES OF HAVING USED AN EXPIRED PRODUCT. THE PRODUCT WAS USED AT 39 MONTHS (EXPIRY PERIOD IS 36 MONTHS). THERE IS A STABILITY STUDY (SP-025) WHICH HAS SUCCESSFUL RESULTS UP TO 42 MONTHS AT ROOM TEMPERATURE (INCLUDING STERILITY). NONETHELESS, IT IS NOT RECOMMENDED TO USE THE PRODUCT BEYOND THE ESTABLISHED EXPIRATION DATE.

    Description of Event or Problem · 1

    THE PRODUCT WAS PLACED ON (B)(6) 2017 AND HAD AN EXPIRATION DATE OF MAR2017. SEVERAL ATTEMPTS WERE MADE TO OBTAIN INFORMATION FROM THE CUSTOMER WITH NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500138 DURAGEN PLUS DURAL REGENERATION MATRIX 1X3 1 PAC N/A GXQ INTEGRA LIFESCIENCES CORPORATION 1140925

    Patients

    Seq Age Sex Outcome Treatment
    1