BLT Ø2.9MM SC, SLACTIVE® 12MM, RXD, LOXI

Additional Manufacturer Narrative

THE BATCH NUMBER COULD BE VERIFIED. OUR MANUFACTURING Q-SYSTEM ASSURES, THAT PRODUCTION AND PROCESS CONTROLS ARE IN PLACE TO ENSURE THAT BATCHES CONFIRM TO THE APPLICABLE SPECIFICATIONS BEFORE THEY ARE DISTRIBUTED. THE NON-INTEGRATION OF AN ENDOSSEOUS DENTAL IMPLANT DURING THE HEALING PHASE IS A KNOWN INHERENT RISK OF THE TREATMENT WITH DENTAL IMPLANTS. MOST IMPLANT FAILURES OCCUR BEFORE OCCLUSAL LOADING (ANALAINEN ET AL. 2013, KOLDSLAND ET AL. 2009). BASED ON CLINICAL STUDIES ABOUT 1-3% OF THE IMPLANTS FAIL WITHIN THE FIRST YEAR AFTER IMPLANTATION (GANELES ET AL. 2008). IMPLANTS MAY HAVE TO BE REMOVED IN CASE ONE OR MORE OF THE IMPLANT SUCCESS CRITERIA ARE NOT MET. IMPLANT SUCCESS CRITERIA ACCORDING TO BUSER ET AL. (1991) ARE: 1. ABSENCE OF PERSISTENT SUBJECTIVE COMPLAINTS SUCH AS PAIN, FOREIGN BODY SENSATION AND/OR DISESTHESIA. 2. ABSENCE OF A RECURRENT PERI-IMPLANT INFECTION WITH SUPPURATION. 3. ABSENCE OF IMPLANT MOBILITY. 4. ABSENCE OF A CONTINUOUS RADIOLUCENCY AROUND THE IMPLANT. THE MANUFACTURER'S TREND ANALYSIS CONFIRMS THAT THE REPORTED EARLY FAILURE RATE ASSOCIATED WITH ITS DENTAL IMPLANTS IS BELOW THE EXPECTED FAILURE RATE FOR THIS TREATMENT AS PUBLISHED IN THE SCIENTIFIC LITERATURE.

Description of Event or Problem

THE CLINICIAN REPORTED THAT 5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN FDI SITE #13 OF THE PATIENT'S MOUTH, THE IMPLANT WAS REMOVED. IT WAS REPORTED THAT TYPE II BONE QUALITY, GOOD HYGIENE AROUND THE IMPLANT, AND IMPLANT MOBILITY AT THE TIME OF THE EVENT. THE PRODUCT WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.