MAUDE Adverse Event Report: SEPTODONT S.A.S. BIODENTINE

Lot Number B28324

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tinnitus (2103)

Event Type  Injury  

Event Description

Spontaneous report, from belgium.Local reference: #(b)(4).Quality complaint was opened: references #(b)(4).This initial non-serious case report was received on 16-jun-2023 from dentist by email and follow-up #1 received on 16-jun-2023 from affiliate by email were processed together.The report described the apparition of tinnitus with the use of suspected device biodentine in a 62 years old male patient (92 kg, 1,76m) after dental procedure.The patient have a medical history of high blood pressure since 2013 and was treated with amplodipine since 2016 for this pathology.He also suffers from sleep apnea syndrome since 2016 and is under unspecified treatment.The patient suffered from renal colic in 2020.It was reported that he patient was non-smoker and was not anxious before dental procedure.On (b)(6) 2023, it was reported that after the used of biodentine the patient experienced tinnitus.At the time of the report, the event tinnitus was not recovered.Other information of product: batch number #b28324 (box batch number:b28482) ; expiry date: 12/2023.This case is serious as it retrieved the following seriousness criterion; reported as other medically important condition by the dentist.Manufacturer's initial comments: based on the information available, this case describes a 62 year old patient who experienced tinnitus with the use of the suspected device biodentine.The dental procedure was performed on (b)(6) 2023 and tinnitus was not recovered at the date of the report on 16 june 2023.Tinnitus has various etiologies such as hearling loss, ear infection or ear canal blockage, injuries, medications, mandibular disorders, blood vessels disorders (eg high blood pressure) or other chronic conditions for instance.The patient suffers from high blood pressure treated with amlodipine but it is not reported if the patient suffered from tinnitus prior the dental procedure.Another possibility is the dental procedure itself (prolonged open position of the jaw) leading to temporo-mandibular joint disorders leading to tinnitus.Biodentine is bioactive dentine substitute composed of minerals used to restaure permanently the dentine, biodentine is in the tooth, does not distribute and does not contain active substances that could lead to tinnitus and is most likely not the cause of tinnitus.Pending quality investigation, the preferred root cause is the dental procedure leading to temporo-manidbular joint disorders and/or patient vascular disorders.Pending quality investigation, no capa is required.

Manufacturer Narrative

Manufacturer's initial comments: based on the information available, this case describes a 62 year old patient who experienced tinnitus with the use of the suspected device biodentine.The dental procedure was performed on (b)(6) 2023 and tinnitus was not recovered at the date of the report on (b)(6) 2023.Tinnitus has various etiologies such as hearling loss, ear infection or ear canal blockage, injuries, medications, mandibular disorders, blood vessels disorders (eg high blood pressure) or other chronic conditions for instance.The patient suffers from high blood pressure treated with amlodipine but it is not reported if the patient suffered from tinnitus prior the dental proocedure.Another possibility is the dental procedure itself (prolonged open position of the jaw) leading to temporo-mandibular joint disorders leading to tinnitus.Biodentine is bioactive dentine substitute composed of minerals used to restaure permanently the dentine, biodentine is in the tooth, does not distribute and does not contain active substances that could lead to tinnitus and is most likely not the cause of tinnitus.Pending quality investigation, the preferred root cause is the dental procedure leading to temporo-manidbular joint disorders and/or patient vascular disorders.Pending quality investigation, no capa is required.

Event Description

Spontaneous report, from belgium.Local reference: (b)(4).Quality complaint was opened: references (b)(4).This initial non-serious case report was received on 16-jun-2023 from dentist by email and follow-up #1 received on 20-jun-2023 from affiliate by email were processed together.Follow-up #2 was received on 27-sep-2023 from quality department via shared platform.The report described the apparition of tinnitus with the use of suspected device biodentine in a 62 years old male patient (92 kg, 1,76m) after dental procedure.The patient have a medical history of high blood pressure since 2013 and was treated with amlodipine since 2016 for this pathology.He also suffers from sleep apnea syndrome since 2016 and is under unspecified treatment.The patient suffered from renal colic in 2020.It was reported that he patient was non-smoker and was not anxious before dental procedure.On 06-apr-2023, it was reported that after the used of biodentine the patient experienced tinnitus.At the time of the report, the event tinnitus was not recovered.Other information of product: batch number #b28324 (powder) and #b28364 (liquid) (box batch number: #b28482) ; expiry date: 12/2023.This case is serious as it retrieved the following seriousness criterion; reported as other medically important condition by the dentist.Manufacturer's initial comments: based on the information available, this case describes a 62 year old patient who experienced tinnitus with the use of the suspected device biodentine.The dental procedure was performed on (b)(6) 2023 and tinnitus was not recovered at the date of the report on 16 june 2023.Tinnitus has various etiologies such as hearing loss, ear infection or ear canal blockage, injuries, medications, mandibular disorders, blood vessels disorders (eg high blood pressure) or other chronic conditions for instance.The patient suffers from high blood pressure treated with amlodipine but it is not reported if the patient suffered from tinnitus prior the dental procedure.Another possibility is the dental procedure itself (prolonged open position of the jaw) leading to temporo-mandibular joint disorders leading to tinnitus.Biodentine is bioactive dentine substitute composed of minerals used to restaur permanently the dentine, biodentine is in the tooth, does not distribute and does not contain active substances that could lead to tinnitus and is most likely not the cause of tinnitus.Pending quality investigation, the preferred root cause is the dental procedure leading to temporo-mandibular joint disorders and/or patient vascular disorders.Pending quality investigation, no capa is required.For final (reportable incident): description of the manufacturer's evaluation concerning possible root causes/causative factors and conclusion: the quality investigations were within specifications and no root cause could be clearly identified.Based on the information available, this case describes a 62 year old patient who experienced tinnitus with the use of the suspected device biodentine.The dental procedure was performed on (b)(6) 2023 and tinnitus was not recovered at the date of the report on 16 june 2023.Tinnitus has various etiologies such as hearing loss, ear infection or ear canal blockage, injuries, medications, mandibular disorders, blood vessels disorders (eg high blood pressure) or other chronic conditions for instance.The patient suffers from high blood pressure treated with amlodipine but it is not reported if the patient suffered from tinnitus prior the dental procedure.Another possibility is the dental procedure itself (prolonged open position of the jaw) leading to temporo-mandibular joint disorders leading to tinnitus.Biodentine is bioactive dentine substitute composed of minerals used to restaur permanently the dentine, biodentine is in the tooth, does not distribute and does not contain active substances that could lead to tinnitus and is most likely not the cause of tinnitus.The preferred root cause is the dental procedure leading to temporo-mandibular joint disorders and/or patient vascular disorders.Biodentine excluded: this incident is most likely linked to the dental procedure associated with the patient vascular disorders medical history.Description of remedial action/corrective action/preventive action/field safety corrective action (fsca): quality investigations within specifications root cause preferred is dental procedure associated with the patient vascular disorders medical history.No capa.

Manufacturer Narrative

Manufacturer's initial comments: based on the information available, this case describes a 62 year old patient who experienced tinnitus with the use of the suspected device biodentine.The dental procedure was performed on (b)(6) 2023 and tinnitus was not recovered at the date of the report on 16 june 2023.Tinnitus has various etiologies such as hearling loss, ear infection or ear canal blockage, injuries, medications, mandibular disorders, blood vessels disorders (eg high blood pressure) or other chronic conditions for instance.The patient suffers from high blood pressure treated with amlodipine but it is not reported if the patient suffered from tinnitus prior the dental proocedure.Another possibility is the dental procedure itself (prolonged open position of the jaw) leading to temporo-mandibular joint disorders leading to tinnitus.Biodentine is bioactive dentine substitute composed of minerals used to restaure permanently the dentine, biodentine is in the tooth, does not distribute and does not contain active substances that could lead to tinnitus and is most likely not the cause of tinnitus.Pending quality investigation, the preferred root cause is the dental procedure leading to temporo-manidbular joint disorders and/or patient vascular disorders.Pending quality investigation, no capa is required.For final (reportable incident): description of the manufacturer's evaluation concerning possible root causes/causative factors and conclusion: the quality investigations were within specifications and no root cause could be clearly identified.Based on the information available, this case describes a 62 year old patient who experienced tinnitus with the use of the suspected device biodentine.The dental procedure was performed on (b)(6) 2023 and tinnitus was not recovered at the date of the report on 16 june 2023.Tinnitus has various etiologies such as hearling loss, ear infection or ear canal blockage, injuries, medications, mandibular disorders, blood vessels disorders (eg high blood pressure) or other chronic conditions for instance.The patient suffers from high blood pressure treated with amlodipine but it is not reported if the patient suffered from tinnitus prior the dental proocedure.Another possibility is the dental procedure itself (prolonged open position of the jaw) leading to temporo-mandibular joint disorders leading to tinnitus.Biodentine is bioactive dentine substitute composed of minerals used to restaure permanently the dentine, biodentine is in the tooth, does not distribute and does not contain active substances that could lead to tinnitus and is most likely not the cause of tinnitus.The preferred root cause is the dental procedure leading to temporo-manidbular joint disorders and/or patient vascular disorders.Biodentine excluded: this incident is most likely linked to the dental procedure associated with the patient vascular disorders medical history.Description of remedial action/corrective action/preventive action/field safety corrective action (fsca): quality investigations within specifications.Root cause preferred is dental procedure associated with the patient vascular disorders medical history.No capa.Correction: "similar incidents with this type of md with a similar root cause" section was corected in the case.

Manufacturer Narrative

Manufacturer's initial comments: based on the information available, this case describes a 62 year old patient who experienced tinnitus with the use of the suspected device biodentine.The dental procedure was performed on (b)(6) 2023 and tinnitus was not recovered at the date of the report on 16 june 2023.Tinnitus has various etiologies such as hearling loss, ear infection or ear canal blockage, injuries, medications, mandibular disorders, blood vessels disorders (eg high blood pressure) or other chronic conditions for instance.The patient suffers from high blood pressure treated with amlodipine but it is not reported if the patient suffered from tinnitus prior the dental proocedure.Another possibility is the dental procedure itself (prolonged open position of the jaw) leading to temporo-mandibular joint disorders leading to tinnitus.Biodentine is bioactive dentine substitute composed of minerals used to restaure permanently the dentine, biodentine is in the tooth, does not distribute and does not contain active substances that could lead to tinnitus and is most likely not the cause of tinnitus.Pending quality investigation, the preferred root cause is the dental procedure leading to temporo-manidbular joint disorders and/or patient vascular disorders.Pending quality investigation, no capa is required.For final (reportable incident): description of the manufacturer's evaluation concerning possible root causes/causative factors and conclusion: the quality investigations were within specifications and no root cause could be clearly identified.Based on the information available, this case describes a 62 year old patient who experienced tinnitus with the use of the suspected device biodentine.The dental procedure was performed on (b)(6) 2023 and tinnitus was not recovered at the date of the report on 16 june 2023.Tinnitus has various etiologies such as hearling loss, ear infection or ear canal blockage, injuries, medications, mandibular disorders, blood vessels disorders (eg high blood pressure) or other chronic conditions for instance.The patient suffers from high blood pressure treated with amlodipine but it is not reported if the patient suffered from tinnitus prior the dental proocedure.Another possibility is the dental procedure itself (prolonged open position of the jaw) leading to temporo-mandibular joint disorders leading to tinnitus.Biodentine is bioactive dentine substitute composed of minerals used to restaure permanently the dentine, biodentine is in the tooth, does not distribute and does not contain active substances that could lead to tinnitus and is most likely not the cause of tinnitus.The preferred root cause is the dental procedure leading to temporo-manidbular joint disorders and/or patient vascular disorders.Biodentine excluded this incident is most likely linked to the dental procedure associated with the patient vascular disorders medical history.Description of remedial action/corrective action/preventive action/field safety corrective action (fsca): quality investigations within specifications root cause preferred is dental procedure associated with the patient vascular disorders medical history.No capa.

Event Description

Spontaneous report, from belgium.Local reference: #(b)(4).Quality complaint was opened: references #(b)(4).This initial non-serious case report was received on 16-jun-2023 from dentist by email and follow-up #1 received on 20-jun-2023 from affiliate by email were processed together.Follow-up #2 was received on 27-sep-2023 from quality department via shared platform.The report described the apparition of tinnitus with the use of supected device biodentine in a 62 years old male patient (92 kg, 1,76m) after dental procedure.The patient have a medical history of high blood pressure since 2013 and was treated with amplodipine since 2016 for this pathology.He also suffers from sleep apnea syndrome since 2016 and is under unspecified treatment.The patient suffered from renal colic in 2020.It was reported that he patient was non-smoker and was not anxious before dental procedure.On 06-apr-2023, it was reported that after the used of biodentine the patient exprienced tinnitus.At the time of the report, the event tinitus was not recovered.Other information of product: batch number #b28324 (powder) and #b28364 (liquid) (box batch number: #b28482); expiry date: 12/2023.This case is serious as it retrieved the following seriousness criterion; reported as other medically important condition by the dentist.Manufacturer's initial comments: based on the information available, this case describes a 62 year old patient who experienced tinnitus with the use of the suspected device biodentine.The dental procedure was performed on (b)(6) 2023 and tinnitus was not recovered at the date of the report on 16 june 2023.Tinnitus has various etiologies such as hearling loss, ear infection or ear canal blockage, injuries, medications, mandibular disorders, blood vessels disorders (eg high blood pressure) or other chronic conditions for instance.The patient suffers from high blood pressure treated with amlodipine but it is not reported if the patient suffered from tinnitus prior the dental proocedure.Another possibility is the dental procedure itself (prolonged open position of the jaw) leading to temporo-mandibular joint disorders leading to tinnitus.Biodentine is bioactive dentine substitute composed of minerals used to restaure permanently the dentine, biodentine is in the tooth, does not distribute and does not contain active substances that could lead to tinnitus and is most likely not the cause of tinnitus.Pending quality investigation, the preferred root cause is the dental procedure leading to temporo-manidbular joint disorders and/or patient vascular disorders.Pending quality investigation, no capa is required.For final (reportable incident): description of the manufacturer's evaluation concerning possible root causes/causative factors and conclusion: the quality investigations were within specifications and no root cause could be clearly identified.Based on the information available, this case describes a 62 year old patient who experienced tinnitus with the use of the suspected device biodentine.The dental procedure was performed on (b)(6) 2023 and tinnitus was not recovered at the date of the report on 16 june 2023.Tinnitus has various etiologies such as hearling loss, ear infection or ear canal blockage, injuries, medications, mandibular disorders, blood vessels disorders (eg high blood pressure) or other chronic conditions for instance.The patient suffers from high blood pressure treated with amlodipine but it is not reported if the patient suffered from tinnitus prior the dental proocedure.Another possibility is the dental procedure itself (prolonged open position of the jaw) leading to temporo-mandibular joint disorders leading to tinnitus.Biodentine is bioactive dentine substitute composed of minerals used to restaure permanently the dentine, biodentine is in the tooth, does not distribute and does not contain active substances that could lead to tinnitus and is most likely not the cause of tinnitus.The preferred root cause is the dental procedure leading to temporo-manidbular joint disorders and/or patient vascular disorders.Biodentine excluded this incident is most likely linked to the dental procedure associated with the patient vascular disorders medical history.Description of remedial action/corrective action/preventive action/field safety corrective action (fsca): quality investigations within specifications root cause preferred is dental procedure associated with the patient vascular disorders medical history.No capa.

Event Description

Spontaneous report, from belgium.Local reference:# (b)(4).Quality complaint was opened: references#: (b)(4).This initial non-serious case report was received on 16-jun-2023 from dentist by email and follow-up #1 received on 20-jun-2023 from affiliate by email.Follow-up #2 was received on 27-sep-2023 from quality department via shared platform.Follow-up 3 was received on 22-nov-2023 from the dentist via email.All the information was processed together.The report described the apparition of tinnitus with the use of suspected device biodentine in a 62 years old male patient (92 kg, 1,76m) after dental procedure.The patient have a medical history of high blood pressure since 2013 and was treated with amlodipine since 2016 for this pathology.He also suffers from sleep apnea syndrome since 2016 and is under unspecified treatment.The patient suffered from renal colic in 2020.It was reported that he patient was non-smoker and was not anxious before dental procedure.On 06-apr-2023, it was reported that a few day after the used of biodentine the patient experienced tinnitus type continuous, non-pulsating, acute noise.At the time of the report, the event tinnitus was not recovered.On an unspecified date, the patient visited to the ent physician.Following tests were performed: ent examination and audiometric test was normal.Doppler of neck vessels was normal.Mri of brain and of auditory canals were normal.At the date of the report, the patient was still suffering from tinnitus.Other information of product: batch number#: b28324 (powder) and #: b28364 (liquid) (box batch number#: b28482); expiry date: 12/2023.Follow-up #3: dentist documentation (test information, outcome, time to onset.And precision on event).The case was downgraded as the dentist confirmed that no serious issue happened as the adr did not endanger the patient's physical integrity.Manufacturer's initial comments: based on the information available, this case describes a 62 year old patient who experienced tinnitus with the use of the suspected device biodentine.The dental procedure was performed on (b)(6) 2023 and tinnitus was not recovered at the date of the report on 16 june 2023.Tinnitus has various etiologies such as hearling loss, ear infection or ear canal blockage, injuries, medications, mandibular disorders, blood vessels disorders (eg high blood pressure) or other chronic conditions for instance.The patient suffers from high blood pressure treated with amlodipine but it is not reported if the patient suffered from tinnitus prior the dental procedure.Another possibility is the dental procedure itself (prolonged open position of the jaw) leading to temporo-mandibular joint disorders leading to tinnitus.Biodentine is bioactive dentine substitute composed of minerals used to restaure permanently the dentine, biodentine is in the tooth, does not distribute and does not contain active substances that could lead to tinnitus and is most likely not the cause of tinnitus.Pending quality investigation, the preferred root cause is the dental procedure leading to temporo-manidbular joint disorders and/or patient vascular disorders.Pending quality investigation, no capa is required.For final (reportable incident): description of the manufacturer's evaluation concerning possible root causes/causative factors and conclusion: the quality investigations were within specifications and no root cause could be clearly identified.Based on the information available, this case describes a 62 year old patient who experienced tinnitus with the use of the suspected device biodentine a few days after the dental procedure.The tinnitus is described as continuous, non-pulsating, high-pitched noise.The dental procedure was performed on (b)(6) 2023 and tinnitus was not recovered at the date of the report on 16 june 2023.Tinnitus has various etiologies such as hearling loss, ear infection or ear canal blockage, injuries, medications, mandibular disorders, blood vessels disorders (eg high blood pressure) or other chronic conditions for instance.Some tinnitus cas be related to stress or idiopathic.The patients was examined by ent specialist: clinical examination + audiometry: normal doppler of neck vessels: normal.Mri of the brain and auditory canals: normal.The patient suffers from high blood pressure treated with amlodipine but it is not reported if the patient had suffered from tinnitus prior the dental procedure.Another possibility is the dental procedure itself (prolonged open position of the jaw) leading to temporo-mandibular joint disorders leading to tinnitus.Biodentine is bioactive dentine substitute composed of minerals used to restaure permanently the dentine, biodentine is in the tooth, does not distribute and does not contain active substances that could lead to tinnitus and is most likely not the cause of tinnitus.The preferred root cause is the dental procedure leading to temporo-manidbular joint disorders and/or patient vascular disorders.Use error/ abnormal use not considered.Biodentine excluded: this incident is most likely linked to the dental procedure associated with the patient vascular disorders medical history.Description of remedial action/corrective action/preventive action/field safety corrective action (fsca): quality investigations within specifications root cause preferred is dental procedure associated with the patient vascular disorders medical history.No capa.

Manufacturer Narrative

Follow-up #3: dentist documentation (test information, outcome, time to onset.And precision on event).The case was downgraded as the dentist confirmed that no serious issue happened as the adr did not endanger the patient's physical integrity.Correction of fda code health effects - impact code and date of report.Manufacturer's initial comments: based on the information available, this case describes a 62 year old patient who experienced tinnitus with the use of the suspected device biodentine.The dental procedure was performed on (b)(6) 2023 and tinnitus was not recovered at the date of the report on 16 june 2023.Tinnitus has various etiologies such as hearling loss, ear infection or ear canal blockage, injuries, medications, mandibular disorders, blood vessels disorders (eg high blood pressure) or other chronic conditions for instance.The patient suffers from high blood pressure treated with amlodipine but it is not reported if the patient suffered from tinnitus prior the dental procedure.Another possibility is the dental procedure itself (prolonged open position of the jaw) leading to temporo-mandibular joint disorders leading to tinnitus.Biodentine is bioactive dentine substitute composed of minerals used to restaure permanently the dentine, biodentine is in the tooth, does not distribute and does not contain active substances that could lead to tinnitus and is most likely not the cause of tinnitus.Pending quality investigation, the preferred root cause is the dental procedure leading to temporo-manidbular joint disorders and/or patient vascular disorders.Pending quality investigation, no capa is required.For final (reportable incident): description of the manufacturer's evaluation concerning possible root causes/causative factors and conclusion: the quality investigations were within specifications and no root cause could be clearly identified.Based on the information available, this case describes a 62 year old patient who experienced tinnitus with the use of the suspected device biodentine a few days after the dental procedure.The tinnitus is described as continuous, non-pulsating, high-pitched noise.The dental procedure was performed on (b)(6) 2023 and tinnitus was not recovered at the date of the report on 16 june 2023.Tinnitus has various etiologies such as hearling loss, ear infection or ear canal blockage, injuries, medications, mandibular disorders, blood vessels disorders (eg high blood pressure) or other chronic conditions for instance.Some tinnitus cas be related to stress or idiopathic.The patients was examined by ent specialist: clinical examination + audiometry: normal.Doppler of neck vessels: normal.Mri of the brain and auditory canals: normal.The patient suffers from high blood pressure treated with amlodipine but it is not reported if the patient had suffered from tinnitus prior the dental procedure.Another possibility is the dental procedure itself (prolonged open position of the jaw) leading to temporo-mandibular joint disorders leading to tinnitus.Biodentine is bioactive dentine substitute composed of minerals used to restaure permanently the dentine, biodentine is in the tooth, does not distribute and does not contain active substances that could lead to tinnitus and is most likely not the cause of tinnitus.The preferred root cause is the dental procedure leading to temporo-manidbular joint disorders and/or patient vascular disorders.Use error/ abnormal use not considered.Biodentine excluded: this incident is most likely linked to the dental procedure associated with the patient vascular disorders medical history.Description of remedial action/corrective action/preventive action/field safety corrective action (fsca): quality investigations within specifications.Root cause preferred is dental procedure associated with the patient vascular disorders medical history.No capa.

Manufacturer Narrative

Follow-up #3: dentist documentation (test information, outcome, time to onset.And precision on event).The case was downgraded as the dentist confirmed that no serious issue happened as the adr did not endanger the patient's physical integrity.Manufacturer's initial comments: based on the information available, this case describes a 62 year old patient who experienced tinnitus with the use of the suspected device biodentine.The dental procedure was performed on (b)(6) 2023 and tinnitus was not recovered at the date of the report on 16 june 2023.Tinnitus has various etiologies such as hearling loss, ear infection or ear canal blockage, injuries, medications, mandibular disorders, blood vessels disorders (eg high blood pressure) or other chronic conditions for instance.The patient suffers from high blood pressure treated with amlodipine but it is not reported if the patient suffered from tinnitus prior the dental procedure.Another possibility is the dental procedure itself (prolonged open position of the jaw) leading to temporo-mandibular joint disorders leading to tinnitus.Biodentine is bioactive dentine substitute composed of minerals used to restore permanently the dentine, biodentine is in the tooth, does not distribute and does not contain active substances that could lead to tinnitus and is most likely not the cause of tinnitus.Pending quality investigation, the preferred root cause is the dental procedure leading to temporo-manidbular joint disorders and/or patient vascular disorders.Pending quality investigation, no capa is required.For final (reportable incident): description of the manufacturer's evaluation concerning possible root causes/causative factors and conclusion: the quality investigations were within specifications and no root cause could be clearly identified.Based on the information available, this case describes a 62 year old patient who experienced tinnitus with the use of the suspected device biodentine a few days after the dental procedure.The tinnitus is described as continuous, non-pulsating, high-pitched noise.The dental procedure was performed on (b)(6) 2023 and tinnitus was not recovered at the date of the report on 16 june 2023.Tinnitus has various etiologies such as hearling loss, ear infection or ear canal blockage, injuries, medications, mandibular disorders, blood vessels disorders (eg high blood pressure) or other chronic conditions for instance.Some tinnitus cas be related to stress or idiopathic.The patients was examined by ent specialist: clinical examination + audiometry: normal.Doppler of neck vessels: normal.Mri of the brain and auditory canals: normal the patient suffers from high blood pressure treated with amlodipine but it is not reported if the patient had suffered from tinnitus prior the dental procedure.Another possibility is the dental procedure itself (prolonged open position of the jaw) leading to temporo-mandibular joint disorders leading to tinnitus.Biodentine is bioactive dentine substitute composed of minerals used to restore permanently the dentine, biodentine is in the tooth, does not distribute and does not contain active substances that could lead to tinnitus and is most likely not the cause of tinnitus.The preferred root cause is the dental procedure leading to temporo-manidbular joint disorders and/or patient vascular disorders.Use error/ abnormal use not considered.Biodentine excluded this incident is most likely linked to the dental procedure associated with the patient vascular disorders medical history.Description of remedial action/corrective action/preventive action/field safety corrective action (fsca): quality investigations within specifications.Root cause preferred is dental procedure associated with the patient vascular disorders medical history.No capa.

Event Description

Spontaneous report, from belgium.Local reference: (b)(4).Quality complaint was opened: references (b)(4).This initial non-serious case report was received on 16-jun-2023 from dentist by email and follow-up #1 received on 20-jun-2023 from affiliate by email.Follow-up #2 was received on 27-sep-2023 from quality department via shared platform.Follow-up 3 was received on 22-nov-2023 from the dentist via email.All the information was processed together.The report described the apparition of tinnitus with the use of suspected device biodentine in a 62 years old male patient (92 kg, 1,76m) after dental procedure.The patient have a medical history of high blood pressure since 2013 and was treated with amlodipine since 2016 for this pathology.He also suffers from sleep apnea syndrome since 2016 and is under unspecified treatment.The patient suffered from renal colic in 2020.It was reported that he patient was non-smoker and was not anxious before dental procedure.On (b)(6) 2023 it was reported that a few day after the used of biodentine the patient exprienced tinnitus type continuous, non-pulsating, acute noise.At the time of the report, the event tinitus was not recovered.On an unspecified date, the patient visited to the ent physician.Following tests were performed: ent examination and audiometric test was normal.Doppler of neck vessels was normal.Mri of brain and of auditory canals were normal.At the date of the report, the patient was still suffering from tinnitus.Other information of product: batch number #b28324 (powder) and #b28364 (liquid) (box batch number: #b28482) ; expiry date: 12/2023.Follow-up #3: dentist documentation (test information, outcome, time to onset.And precision on event).The case was downgraded as the dentist confirmed that no serious issue happend as the adr did not endanger the patient's physical integrity.Manufacturer's initial comments: based on the information available, this case describes a 62 year old patient who experienced tinnitus with the use of the suspected device biodentine.The dental procedure was performed on (b)(6) 2023 and tinnitus was not recovered at the date of the report on (b)(6) 2023.Tinnitus has various etiologies such as hearling loss, ear infection or ear canal blockage, injuries, medications, mandibular disorders, blood vessels disorders (eg high blood pressure) or other chronic conditions for instance.The patient suffers from high blood pressure treated with amlodipine but it is not reported if the patient suffered from tinnitus prior the dental proocedure.Another possibility is the dental procedure itself (prolonged open position of the jaw) leading to temporo-mandibular joint disorders leading to tinnitus.Biodentine is bioactive dentine substitute composed of minerals used to restaure permanently the dentine, biodentine is in the tooth, does not distribute and does not contain active substances that could lead to tinnitus and is most likely not the cause of tinnitus.Pending quality investigation, the preferred root cause is the dental procedure leading to temporo-manidbular joint disorders and/or patient vascular disorders.Pending quality investigation, no capa is required.For final (reportable incident): description of the manufacturer's evaluation concerning possible root causes/causative factors and conclusion: the quality investigations were within specifications and no root cause could be clearly identified.Based on the information available, this case describes a 62 year old patient who experienced tinnitus with the use of the suspected device biodentine a few days after the dental procedure.The tinnitus is described as continuous, non-pulsating, high-pitched noise.The dental procedure was performed on (b)(6) 2023 and tinnitus was not recovered at the date of the report on 16 june 2023.Tinnitus has various etiologies such as hearling loss, ear infection or ear canal blockage, injuries, medications, mandibular disorders, blood vessels disorders (eg high blood pressure) or other chronic conditions for instance.Some tinnitus cas be related to stress or idiopathic.The patients was examined by ent specialist: clinical examination + audiometry: normal.Doppler of neck vessels: normal.Mri of the brain and auditory canals: normal the patient suffers from high blood pressure treated with amlodipine but it is not reported if the patient had suffered from tinnitus prior the dental procedure.Another possibility is the dental procedure itself (prolonged open position of the jaw) leading to temporo-mandibular joint disorders leading to tinnitus.Biodentine is bioactive dentine substitute composed of minerals used to restaure permanently the dentine, biodentine is in the tooth, does not distribute and does not contain active substances that could lead to tinnitus and is most likely not the cause of tinnitus.The preferred root cause is the dental procedure leading to temporo-manidbular joint disorders and/or patient vascular disorders.Use error/ abnormal use not considered.Biodentine excluded: this incident is most likely linked to the dental procedure associated with the patient vascular disorders medical history.Description of remedial action/corrective action/preventive action/field safety corrective action (fsca): quality investigations within specifications root cause preferred is dental procedure associated with the patient vascular disorders medical history.No capa.

• Brand Name: BIODENTINE
• Type of Device: BIODENTINE
• Manufacturer (Section D): SEPTODONT S.A.S.; 58, rue du pont de creteil; saint maur, cedex val-de-marne, 94100 ; FR 94100
• Manufacturer (Section G): SEPTODONT S.A.S.; 58, rue du pont de creteil; saint maur, cedex val-de-marne, 94100 ; FR 94100
• Manufacturer Contact: 58, rue du pont de creteil; saint maur, cedex val-de-marne, 94100
• MDR Report Key: 17635147
• MDR Text Key: 322098288
• Report Number: 9610964-2023-00017
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: B28324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 09/27/2023; 09/27/2023; 11/22/2023; 11/22/2023
• Supplement Dates FDA Received: 10/20/2023; 11/10/2023; 12/05/2023; 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: #1: AMLODIPINE.BATCH: UNKNOWN.; #1: AMLODIPINE.BATCH: UNKNOWN.; #1: AMLODIPINE.BATCH: UNKNOWN.; #1: AMLODIPINE.BATCH: UNKNOWN.; #1: AMLODIPINE.BATCH: UNKNOWN.
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male