BEUDAMED
    FDA Adverse Event Other Summary report: N

    DYNABLAST PUTTY 1CC

    MDR report key: 3060463 · Received April 11, 2013

    Report

    Report Number
    3005990499-2013-00001
    Event Type
    Other
    Date Received
    April 11, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 18, 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 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. REVIEWS OF THE STERILIZATION CERTIFICATE OF PROCESSING VERIFIED THAT THIS PRODUCT WAS STERILIZED ON (B)(6) 2011, IN LOAD 11D01 AND WAS STERILIZED FROM DOSE 25.7 KGY TO 34.8 KGY. THE PRODUCT WAS STERILIZED WITHIN SPECIFICATIONS: MIN DOSE 25.0 KGY TO MAX DOSE 35.0 KGY. THIS PRODUCT WAS TERMINALLY STERILIZED TO A STERILITY ASSURANCE LEVEL (SAL) OF 10-6. KEYSTONE DENTAL'S INVESTIGATION DID NOT REVEAL ANY MANUFACTURING OR STERILIZATION ISSUES. THE ROOT CAUSE OF THIS OCCURRENCE COULD NOT BE DETERMINED. KEYSTONE DENTAL DOES NOT ANTICIPATE ANY ADDITIONAL INFORMATION AND THEREFORE, CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    THE CLINICIAN REPORTED THAT ONE OF HIS PATIENTS, WHO HAD A BONE AUGMENTATION PROCEDURE COMPLETED PREVIOUSLY AT HIS OFFICE, WAS CONSULTING WITH A DIFFERENT PHYSICIAN/SURGEON FOR DENTAL IMPLANT PLACEMENT WHEN THE CONSULTING PHYSICIAN DIAGNOSED AN APICAL LESION. THE CLINICIAN REPORTED THAT A PLASTIC LIKE MATERIAL WAS REMOVED FROM THE SITE AND HAD BEEN SUBMITTED TO A LAB FOR PATHOLOGICAL ANALYSIS. ACCORDING TO THE REPORTING CLINICIAN; DYNABLAST PUTTY WAS PLACED FOLLOWING AN IMMEDIATE EXTRACTION AT DENTAL SITE (30) DURING A SOCKET RESTORATION PROCEDURE ON (B)(6) 2011. THIS PATIENT WAS SEEN 18 MONTHS FOLLOWING THE PROCEDURE ON (B)(6) 2013, DUE TO ISSUES WITH A DIFFERENT TOOTH. A SMALL FISTULA WAS NOTED AT SITE 30. THE PATIENT DID NOT COMPLAIN OF PAIN OR ANY OTHER ISSUES. A CALL TO THE CONSULTING PHYSICIAN/SURGEON, WHO DISCOVERED THE APICAL LESION, RELATED THAT THE PATIENT CONSULTED WITH HIM 3 WEEKS AGO (SPECIFIC DATE NOT PROVIDED) AT WHICH TIME THE LESION WAS DISCOVERED, THE MATERIAL WAS REMOVED AND THE SITE WAS COVERED. THE CLINICIAN CONFIRMED THAT SAMPLES OF THE PLASTIC LIKE MATERIAL WERE SENT FOR PATHOLOGICAL EXAMINATION. KEYSTONE DENTAL INQUIRED IF THE PICTURES OR PATHOLOGY RESULTS WOULD BE AVAILABLE FOR REVIEW AND THE CONSULTING CLINICIAN WAS RELUCTANT TO SHARE ANY ADDITIONAL DETAILS AND CITED PATIENT PRIVACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155536 DYNABLAST PUTTY 1CC NUN KEYSTONE DENTAL NA 110592

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other