BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYNABLAST PUTTY 1CC

    MDR report key: 3410415 · Received October 8, 2013

    Report

    Report Number
    3005990499-2013-00002
    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 CONTRAST MANUFACTURED 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 ADD'L COMPLAINTS FROM THIS LOT WERE IDENTIFIED DURING A REVIEW OF KEYSTONE COMPLAINTS DATABASE. INTEGRA PERFORMED A DETAILED REVIEW OF THE MFG RECORDS AND VERIFIED THAT PRODUCT WAS MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE PRODUCT SPECS. 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 12D01 AND WAS STERILIZED FROM DOSE 25.0 KGY TO 33.9 KGY. THE PRODUCT WAS STERILIZED WITHIN SPECS OF MIN DOSE 25.0 KGY TO MAX DOSE 35.0 KGY. STERIGENICS CERTIFIES THE MATERIALS (PRODUCTS) RECEIVED THE INDICATED DOSES WITHIN THE PRECISION AND ACCURACY OF THE DOSIMETRY SYSTEM EMPLOYED. THIS PRODUCT WAS TERMINALLY STERILIZED TO A STERILITY ASSURANCE LEVEL (SAL) OF 10-6. KEYSTONE DENTAL'S INVESTIGATION DID NOT REVEAL ANY MFG OR STERILIZATION ISSUES. THE ROOT CAUSE OF THIS OCCURRENCE COULD NOT BE DETERMINED. KEYSTONE DENTAL DOES NOT ANTICIPATE ANY ADD'L INFO AND THEREFORE, 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, THE AREA WAS STILL SOFT. 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. IN THIS PT HE PLACED AN IMPLANT BUT IT HAD COMPROMISED STABILITY BECAUSE OF THE LACK OF BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509917 DYNABLAST PUTTY 1CC NUN KEYSTONE DENTAL NA 120589

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other