BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYNABLAST PASTE 0.5CC

    MDR report key: 1779252 · Received July 29, 2010

    Report

    Report Number
    2090010-2010-00002
    Event Type
    Other
    Date Received
    July 29, 2010
    Date of Event
    February 20, 2008
    Report Date
    July 29, 2010
    Manufacturer
    ISOTIS ORTHOBIOLOGICS, INC.
    Product Code
    NUN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA'S INVESTIGATION DETERMINED THAT BATCH RECORDS, DEMINERALIZATION RECORDS, STERILIZATION RECORDS, DONOR RECORDS, AND OUR RETENTION SAMPLE THAT WERE REVIEWED SHOWED NO ANOMALIES. THE MEDICAL DIRECTOR OF THE TISSUE BANK WHO SUPPLIED THE DONATED BONE MADE THE INITIAL DONOR SUITABILITY DECISION BASED ON THE DONOR EVAL RECORDS, AUTOPSY REPORT, SEROLOGY TESTS, AND ANALYSIS AND MEDICAL SOCIAL RISK FACTORS. IT WAS CONCLUDED THAT THERE WAS NOTHING IN THEIR MEDICAL RECORDS THE WOULD INDICATE THE DONOR WAS POSITIVE FOR, OR EVENT AT RISK FOR EPSTEIN-BARR VIRUS. (EBV). ALL DONOR MUST MEET THE ACCEPTANCE CRITERIA ESTABLISHED BY THE FDA AND AATB. EACH LOT CAREFULLY SCREENED AND SELECTED DONATED BONE IS PROCESSED THROUGH OUR PROPRIETARY ACID WASH PROCESS WHICH HAS BEEN PROVEN TO EFFECTIVELY INACTIVATE VIRUSES WHEN THE PROCESS IS VIRALLY CHALLENGED. IN ADDITION TO THE ACID PROCESSING, DYNABLAST PASTE IS TERMINALLY STERILIZED BY E-BEAM IRRADIATION, AT 25-35 KGY WITH A 10-6 (ONE IN ONE MILLION) SAL (STERILITY ASSURANCE LEVEL) WHICH HAS BEEN SHOWN TO EFFECTIVELY REDUCE MICROBIAL CONTAMINATION. THE STERILIZATION RECORDS WERE REVIEWED AND THE PRODUCT WAS VERIFIED TO BE STERILIZED IN ACCORDANCE WITH OUR REQUIREMENTS WITH NO DEVIATIONS NOTED IN THE PROCESSING RECORDS. THESE DEVICES ARE MANUFACTURED IN NEAR ASEPTIC PROCESSING CONDITIONS TO MINIMIZE ANY MICROBIAL OR VIRAL CONTAMINATION IN THE FINAL PRODUCT. ALL DONORS ARE PRESCREENED BY A MEDICAL DIRECTOR AT OUR TISSUE BANK AND ALL DONORS MUST MEET THE ACCEPTANCE CRITERIA ESTABLISHED BY THE FDA AND THE AMERICAN ASSOCIATION OF TISSUE BANKS. THERE IS NOT DISCERNABLE ROOT CAUSE BECAUSE POSSIBILITY OF EBV TRANSMISSION THROUGH OUR BONE HAS NOT BEEN ESTABLISHED. SINCE THE EPSTEIN BARR VIRUS IS PRESENT IN OVER 90% OF THE POPULATION, AND IT IS TRANSMITTED THROUGH SALIVA, THE POSSIBILITY OF DISEASE TRANSMISSION THROUGH OUR HIGHLY PROCESSED AND TERMINALLY STERILIZED BONE IS HIGHLY UNLIKELY. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES. CORRECTION ACTION IS NOT REQUIRED, THIS IS AN UNCONFIRMED AND ISOLATED EVENT.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A PT IN WHOM THE PRODUCT WAS USED DURING A DENTAL IMPLANT PROCEDURE, ALLEGED THAT HE CONTRACTED EPSTEIN-BARR VIRUS FROM THE BONE GRAFT. THE GRAFT HAS BEEN IN PLACE SINCE 2008. THE PT REPORTED THAT HE HAD HOSPITAL TEST COSTING HIM $4,000. INFO ON DIAGNOSTIC TESTING THAT WAS DONE IS NOT AVAILABLE. THE PT HAD A YOUNG CHILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNABLAST PASTE 0.5CC DYNABLAST NUN ISOTIS ORTHOBIOLOGICS, INC. 071869

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other DENTAL IMPLANT SYSTEM