BIODENTINE

Description of Event or Problem

MFR REPORT #: (B)(4) / 1000477999-2024-00005 #1: NECROSIS V27.0 (APPARENTLY THE TOOTH NECROSED ): FROM TO - SERIOUS - UNKNOWN #2: BURNING GUM V27.0 (SEVERE PAIN AND BURNING OF THE TEETH AND GUMS): FROM TO - NOT SERIOUS - UNKNOWN #3: GUM PAIN V27.0 (SEVERE PAIN AND BURNING OF THE TEETH AND GUMS): FROM TO - NOT SERIOUS - NOT RECOVERED/NOT RESOLVED SPONTANEOUS REPORT FROM FRANCE LOCAL REFERENCE: (B)(4) THIS INITIAL SERIOUS CASE REPORT WAS IDENTIFIED ON (B)(6) 2024 FROM THE PATIENT VIA NON-SEPTODONT SOCIAL MEDIA WATCH. INCIDENT DESCRIPTION NARRATIVE: THE REPORT DESCRIBED A NECROSIS AND GINGIVAL PAIN AND DISCOMFORT WITH SUSPECTED MEDICAL DEVICE BIODENTINE FOLLOWING AN UNSPECIFIED PROCEDURE. THIS CASE OCCURED ON A FEMALE PATIENT. THE PATIENT HAD A CARIOUS WISDOM TOOTH SINCE ABOUT 2 YEARS, AND PAIN PARTICULARLY IN THE GUMS BETWEEN THE TWO TEETH SINCE (B)(6) 2024. ON AN UNKNOWN DATE, AFTER THE DENTIST USED BIODENTINE, THE PATIENT EXPERIENCED SEVERE PAIN AND BURNING IN THE GUMS, AND THE TOOTH NECROSED THE TOOTH WAS DEVITALIZED AND X-DENTAL RAY WERE PERFORMED ON AN UNKNOWN DATE. NO OTHER INFORMATION AVAILABLE. OTHER INFORMATION OF PRODUCT: BIODENTINE, BATCH NUMBER: UNKNOWN, EXPIRY DATE: UNKNOWN. THIS CASE WAS CONSIDERED AS SERIOUS DUE TO OTHER MEDICALLY IMPORTANT CONDITION. FOR FINAL (REPORTABLE INCIDENT): DESCRIPTION OF THE MANUFACTURER¿S EVALUATION CONCERNING POSSIBLE ROOT CAUSES/CAUSATIVE FACTORS AND CONCLUSION: THE REPORT DESCRIBED A NECROSIS AND GINGIVAL PAIN AND DISCOMFORT WITH SUSPECTED MEDICAL DEVICE BIODENTINE FOLLOWING AN UNSPECIFIED PROCEDURE. INDEED, AFTER THE DENTIST USED BIODENTINE, THE PATIENT EXPERIENCED SEVERE PAIN AND BURNING IN THE GUMS, AND THE TOOTH NECROSED. IT WAS REPORTED THAT THE PATIENT HAD A CARIOUS WISDOM TOOTH SINCE ABOUT 2 YEARS, AND PAIN PARTICULARLY IN THE GUMS BETWEEN THE TWO TEETH SINCE (B)(6) 2024. THE TIME TO ONSET BETWEEN THE APPLICATION OF BIODENTINE AND THE EVENTS IS NOT REPORTED. NONETHELESS, IN THE CONTEXT OF THE CARIOUS WISDOM TOOTH SINCE 2 YEARS ASSOCIATED WITH PAIN IN THE GUMS, THE EVENTS REPORTED ARE MOSTLY DUE TO THE PATIENT CONDITIONS AND NOT THE PRODUCT. INDEED, A DELAY IN TREATMENT (2 YEARS) MAY HAVE LEAD TO A TOOTH ALREADY IN NECROSIS STAGE. INDEED, THE IFU STATES TO ASSESS PULP VITALITY USING THE USUAL TESTS PRIOR USING BIODENTINE. WITHOUT FURTHER INFORMATION, THE ROOT CAUSE IS TRACED TO PTHE PATIENT MEDICAL CONDITION. USE ERROR/ABNORMAL USE CONSIDERED (NO PULP VITALITY ASSESSMENT) BUT NOT CONFIRMED. DESCRIPTION OF REMEDIAL ACTION/CORRECTIVE ACTION/PREVENTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION (FSCA): NA, NOT BATCH NOR SAMPLES RECEIVED. NO QUALITY INVESTIGATIONS PERFORMED. FINAL COMMENTS FROM THE MANUFACTURER: NO CAPA RCA : ADVERSE EVENT RELATED TO PATIENT CONDITION NO QUALITY INVESTIGATIONS PERFORMED.

Additional Manufacturer Narrative

REPROCESSED: UNK.

Description of Event or Problem

SPONTANEOUS REPORT FROM FRANCE LOCAL REFERENCE: (B)(4). THIS INITIAL SERIOUS CASE REPORT WAS IDENTIFIED ON (B)(6) 2024 FROM THE PATIENT VIA NON-SEPTODONT SOCIAL MEDIA WATCH. FOLLOW-UP #1 WAS REGISTERED ON (B)(6) 2024 FOLLOWING AN INTERNAL REVIEW. DESCRIPTION OF THE INCIDENT: THE REPORT DESCRIBED A NECROSIS AND GINGIVAL PAIN AND DISCOMFORT WITH SUSPECTED MEDICAL DEVICE BIODENTINE FOLLOWING AN UNSPECIFIED PROCEDURE. THIS CASE OCCURED ON A 35-YEAR-OLD FEMALE PATIENT. THE PATIENT HAD A CARIOUS WISDOM TOOTH SINCE ABOUT 2 YEARS, AND PAIN PARTICULARLY IN THE GUMS BETWEEN THE TWO TEETH SINCE ON (B)(6) 2024. ON AN UNKNOWN DATE, AFTER THE DENTIST USED BIODENTINE, THE PATIENT EXPERIENCED SEVERE PAIN AND BURNING IN THE GUMS, AND THE TOOTH NECROSED THE TOOTH WAS DEVITALIZED AND X-DENTAL RAY WERE PERFORMED ON AN UNKNOWN DATE. NO OTHER INFORMATION AVAILABLE. OTHER INFORMATION OF PRODUCT: BIODENTINE, BATCH NUMBER: UNKNOWN, EXPIRY DATE: UNKNOWN. THIS CASE WAS CONSIDERED AS SERIOUS DUE TO OTHER MEDICALLY IMPORTANT CONDITION. FOLLOW-UP #1 RECEIVED ON (B)(6) 2024: AMENDMENT FOLLOWING INTERNAL REVIEW, PATIENT DATE OF BIRTH AND AGE ADDED. FOR FINAL (REPORTABLE INCIDENT): DESCRIPTION OF THE MANUFACTURER'S EVALUATION CONCERNING POSSIBLE ROOT CAUSES/CAUSATIVE FACTORS AND CONCLUSION: THE REPORT DESCRIBED A NECROSIS AND GINGIVAL PAIN AND DISCOMFORT WITH SUSPECTED MEDICAL DEVICE BIODENTINE FOLLOWING AN UNSPECIFIED PROCEDURE. INDEED, AFTER THE DENTIST USED BIODENTINE, THE PATIENT EXPERIENCED SEVERE PAIN AND BURNING IN THE GUMS, AND THE TOOTH NECROSED. IT WAS REPORTED THAT THE PATIENT HAD A CARIOUS WISDOM TOOTH SINCE ABOUT 2 YEARS, AND PAIN PARTICULARLY IN THE GUMS BETWEEN THE TWO TEETH SINCE ON (B)(6) 2024. THE TIME TO ONSET BETWEEN THE APPLICATION OF BIODENTINE AND THE EVENTS IS NOT REPORTED. NONETHELESS, IN THE CONTEXT OF THE CARIOUS WISDOM TOOTH SINCE 2 YEARS ASSOCIATED WITH PAIN IN THE GUMS, THE EVENTS REPORTED ARE MOSTLY DUE TO THE PATIENT CONDITIONS AND NOT THE PRODUCT. INDEED, A DELAY IN TREATMENT (2 YEARS) MAY HAVE LEAD TO A TOOTH ALREADY IN NECROSIS STAGE. INDEED THE IFU STATES TO ASSESS PULP VITALITY USING THE USUAL TESTS PRIOR USING BIODENTINE. WITHOUT FURTHER INFORMATION, THE ROOT CAUSE IS TRACED TO THE PATIENT MEDICAL CONDITION. USE ERROR/ABNORMAL USE CONSIDERED (NO PULP VITALITY ASSESSMENT) BUT NOT CONFIRMED. FU1: NO CHANGE IN ASSESSMENT. ADVERSE EVENT RELATED TO PATIENT CONDITION. DESCRIPTION OF REMEDIAL ACTION/CORRECTIVE ACTION/PREVENTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION (FSCA): NA, NOT BATCH NOR SAMPLES RECEIVED. NO QUALITY INVESTIGATIONS PERFORMED. FINAL COMMENTS FROM THE MANUFACTURER: NO CAPA. RCA: ADVERSE EVENT RELATED TO PATIENT CONDITION. NO QUALITY INVESTIGATIONS PERFORMED.

Additional Manufacturer Narrative

FOR FINAL (REPORTABLE INCIDENT): DESCRIPTION OF THE MANUFACTURER'S EVALUATION CONCERNING POSSIBLE ROOT CAUSES/CAUSATIVE FACTORS AND CONCLUSION: THE REPORT DESCRIBED A NECROSIS AND GINGIVAL PAIN AND DISCOMFORT WITH SUSPECTED MEDICAL DEVICE BIODENTINE FOLLOWING AN UNSPECIFIED PROCEDURE. INDEED, AFTER THE DENTIST USED BIODENTINE, THE PATIENT EXPERIENCED SEVERE PAIN AND BURNING IN THE GUMS, AND THE TOOTH NECROSED. IT WAS REPORTED THAT THE PATIENT HAD A CARIOUS WISDOM TOOTH SINCE ABOUT 2 YEARS, AND PAIN PARTICULARLY IN THE GUMS BETWEEN THE TWO TEETH SINCE ON (B)(6) 2024. THE TIME TO ONSET BETWEEN THE APPLICATION OF BIODENTINE AND THE EVENTS IS NOT REPORTED. NONETHELESS, IN THE CONTEXT OF THE CARIOUS WISDOM TOOTH SINCE 2 YEARS ASSOCIATED WITH PAIN IN THE GUMS, THE EVENTS REPORTED ARE MOSTLY DUE TO THE PATIENT CONDITIONS AND NOT THE PRODUCT. INDEED, A DELAY IN TREATMENT (2 YEARS) MAY HAVE LEAD TO A TOOTH ALREADY IN NECROSIS STAGE. INDEED THE IFU STATES TO ASSESS PULP VITALITY USING THE USUAL TESTS PRIOR USING BIODENTINE. WITHOUT FURTHER INFORMATION, THE ROOT CAUSE IS TRACED TO THE PATIENT MEDICAL CONDITION. USE ERROR/ABNORMAL USE CONSIDERED (NO PULP VITALITY ASSESSMENT) BUT NOT CONFIRMED. FU1: NO CHANGE IN ASSESSMENT. ADVERSE EVENT RELATED TO PATIENT CONDITION. DESCRIPTION OF REMEDIAL ACTION/CORRECTIVE ACTION/PREVENTIVE ACTION/FIELD SAFETY CORRECTIVE ACTION (FSCA): NA, NOT BATCH NOR SAMPLES RECEIVED. NO QUALITY INVESTIGATIONS PERFORMED. FINAL COMMENTS FROM THE MANUFACTURER: NO CAPA. RCA: ADVERSE EVENT RELATED TO PATIENT CONDITION. NO QUALITY INVESTIGATIONS PERFORMED.