BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYNABLAST PUTTY 1CC

    MDR report key: 3452870 · Received October 25, 2013

    Report

    Report Number
    3005990499-2013-00006
    Event Type
    Other
    Date Received
    October 25, 2013
    Date of Event
    September 1, 2013
    Report Date
    September 27, 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 MANUFACTURER FOR KEYSTONE DENTAL BY INTEGRA LIFESCIENCES. KEYSTONE DENTAL HAS AN EXCLUSIVE LICENSE TO SELL THE DYNABLAST PRODUCT FOR DENTAL APPLICATIONS FROM INTEGRA LIFESCIENCES, THE DEVELOPER OF THE PRODUCT. NO ADDITIONAL COMPLAINTS FROM THIS LOT WERE IDENTIFIED DURING A REVIEW OF KEYSTONE COMPLAINTS DATABASE. INTEGRA PERFORMED A DETAILED REVIEW OF THE MANUFACTURING RECORDS AND VERIFIED THAT PRODUCT WAS MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE PRODUCT SPECIFICATIONS. INTEGRA'S REVIEW INCLUDED THE BATCH RECORDS, TISSUE BANK DONOR RECORD, DEMINERALIZATION RECORD, AND STERILIZATION RECORD. THERE WERE NO ANOMALIES FOUND WITHIN THESE RECORDS. A REVIEW OF THE STERILIZATION CERTIFICATE OF PROCESSING VERIFIED THAT THE PRODUCT WAS STERILIZED ON (B)(4) 2012, IN LOAD 12J25 AND WAS STERILIZED FROM DOES 25.0 KGY TO 33.9 KGY. THE PRODUCT WAS STERILIZED WITHIN SPECIFICATIONS OF MIN DOSE 25.0 KGY TO MAX DOSE 35.0 KGY. STERIGENICS CERTIFIES THE MATERIALS (PRODUCTS) RECEIVED THE INDICATED DOSES WITHIN THE PRECISIONS AND ACCURACY OF THE DOSIMETRY SYSTEM EMPLOYED. THIS PRODUCT WAS STERILIZED TO A STERILITY ASSURANCE LEVEL (SAL) OF 10-6. KEYSTONE DENTAL'S INVESTIGATION DID NOT REVEAL ANY MANUFACTURING OR STERILIZATION ISSUES. THE IFU STATES SITES GRAFTED WITH DYNABLAST SHOULD BE ALLOWED TO HEAL APPROXIMATELY 6 MONTHS PRIOR TO IMPLANT PLACEMENT. KEYSTONE DENTAL CONSIDERS THIS INVESTIGATION CLOSED. (B)(4).

    Description of Event or Problem · 1

    THE CLINICIAN CONTACTED KEYSTONE DENTAL 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 DYNABLAT PRODUCT IN MANY SUCCESSFUL 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 NUMBER 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549275 DYNABLAST PUTTY 1CC NUN KEYSTONE DENTAL NA 121318

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention