THE CLINICIAN CONTACTED KEYSTONE DENTAL ON (B)(6) 2013 AND REPORTED THAT A PT COMPLAINED OF A BURNING SENSATION IMMEDIATELY AFTER PLACEMENT OF DYANBLAST PASTE. ACCORDING TO THE INCIDENT NARRATIVE AN IMPLANT WAS PLACED ON (B)(6) 2012 AT (B)(6). ON (B)(6) 2013 THE PT COMPLAINED OF SORENESS AND IRRITATION. ANTIBIOTICS TREATMENT WAS PRESCRIBED ON (B)(6) 2013. THE SITE LOOKED GOOD DURING A POST OP VISIT ON (B)(6) 2013, BUT CORONAL BONE LOSS WAS OBSERVED ON (B)(6) 2013, THE AREA WAS RED AND INFLAMED. A SECOND ROUND OF ANTIBIOTICS TREATMENT WAS PRESCRIBED ON (B)(6) 2013, 9MM CRESTAL BONE LOSS WAS ALSO EVIDENT. THE SITE WAS GRAFTED TO MITIGATE CRESTAL BONE LOSS. ON (B)(6) 2013 THE AREA WAS STILL RED AND INFLAMED. THE CLINICIAN REMOVED THE IMPLANT AND GRAFT.
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Patient 1
THIS PRODUCT IS CONTRACT MANUFACTURED 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 (B)(4) 2012, IN LOAD 12H02 AND WAS STERILIZED FROM DOSE 28.4 KGY TO 30.9 KGY. THE PRODUCT WAS STERILIZED WITHIN SPECIFICATION OF MIN DOSE 25.0 KGY TO MAX DOSE 35.0 KGY. (B)(4) CERTIFIES THE MATERIALS (PRODUCTS) RECEIVED THE INDICATED DOSES WITHIN THE PRECISION 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. HOWEVER, IT WAS DETERMINED THAT THE SITE WAS INFLAMED AT THE TIME OF GRAFTING. THE IFU WARNS AGAINST THE USE OF DYNABLAST IN CONTRAINDICATED PTS. KEYSTONE DENTAL REFERENCE: (B)(4).