BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYNABLAST PUTTY 1CC

    MDR report key: 3410454 · Received October 8, 2013

    Report

    Report Number
    3005990499-2013-00003
    Event Type
    Other
    Date Received
    October 8, 2013
    Date of Event
    September 1, 2013
    Report Date
    September 10, 2013
    Manufacturer
    KEYSTONE DENTAL
    Product Code
    NUN
    PMA / PMN Number
    K043573
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS CONTRACT MANUFACTURED FOR (B)(4) BY INTEGRA LIFESCIENCES. (B)(4) HAS AN EXCLUSIVE LICENSE TO SELL THE DYNABLAST PRODUCT FOR DENTAL APPLICATIONS FROM INTEGRA LIFESCIENCE, THE DEVELOPER OF THE PRODUCT. NO LOT NUMBER WAS PROVIDED DESPITE SEVERAL F/U ATTEMPTS, NOT HAVING A LOT NUMBER PRECLUDED A THOROUGH REVIEW OF KEYSTONE DENTAL COMPLAINT DATABASE AND INTEGRA'S ABILITY TO PERFORMED A DETAILED REVIEW OF BATCH RECORDS, TISSUE BANK DONOR RECORD, DEMINERALIZATION RECORD, AND STERILIZATION RECORD. THE ROOT CAUSE OF THIS OCCURRENCE COULD NOT BE DETERMINED. KEYSTONE DENTAL DOES NOT ANTICIPATED ANY ADD'L INFO AND THEREFORE, CONSIDERS THIS INVESTIGATION CLOSED. (B)(4).

    Description of Event or Problem · 1

    THE CLINICIAN CONTACTED (B)(4) ON (B)(6) 2013 AND STATED HE REOPENED A SITE GRAFTED WITH DYNABLAST AND FOUND THAT THERE WAS NO SOLID BONE. THIS PROCEDURE WAS COMPLETED IN (B)(6) 2013, AND IMPLANTATION WAS ATTEMPTED RECENTLY (ABOUT 5 MONTHS AFTER BONE GRAFTING). THE CLINICIAN USES DYNABLAST PRODUCT IN MANY SUCCESSFULLY CASES SINCE 2009, AND NOTED THAT THE PT WAS A GOOD CANDIDATE FOR THIS PROCEDURE AND IS RELATIVELY HEALTHY. THE SITE WAS RE-GRAFTED AND THE PT WAS SENT HOME FOR A COUPLE MONTHS TO ALLOW BONE TO FILL THE SITE. THE GRAFT WAS PLACED AT MOLAR #19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509899 DYNABLAST PUTTY 1CC NUN KEYSTONE DENTAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention