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 DYNABLAST 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.
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Patient 1
THIS PRODUCT IS CONTRACT MANUFACTURER FOR KEYSTONE DENTAL BY (B)(4). KEYSTONE DENTAL HAS AN EXCLUSIVE LICENSE TO SELL THE DYNABLAST PRODUCT FOR DENTAL APPLICATIONS FROM (B)(4), THE DEVELOPER OF THE PRODUCT. NO ADDITIONAL COMPLAINTS FROM THIS LOT WERE IDENTIFIED DURING A REVIEW OF KEYSTONE COMPLAINTS DATABASE. (B)(4) PERFORMED A DETAILED REVIEW OF THE MANUFACTURING RECORDS AND VERIFIED THAT PRODUCT WAS MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE PRODUCT SPECIFICATIONS. (B)(4) 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 07/30/2012, IN (B)(4). (B)(4) CERTIFIES THE MATERIALS (PRODUCTS) RECEIVED THE INDICATED DOSES WITHIN THE PRECISIONS AND ACCURACY OF THE DOSIMETRY SYSTEM EMPLOYED. THIS PRODUCT WAS STERILIZED TO (B)(4). 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. KEYSTONE DENTAL REFERENCE: (B)(4).