MAUDE Adverse Event Report: SEPTODONT SAS BIODENTINE; BIOACTIVE DENTAL SUBSTITUTE

Lot Number B22896B

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Pain (1994); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

Preliminary results and conclusion of manufacturer's investigation: the patient experienced gum necrosis and loss, unexpected for biodentine (biocompatible product).Batch and incident anteriority did not identify similar events with the batch number or similar incidents.The route cause to consider for these events are: a traumatic /iatrogenic surgery (flap) that may have affected the gum hill, and the vasoconstrictor, often included in the local anesthetics that may have impaired the blood flow leading notably to the reported events in case of rapid injection.Based on the preliminary analysis, and in the absence of anteriority on the batch and similar incidents, no capa is required.

Event Description

Spontaneous report, from (b)(6).Local reference: (b)(4).Linked cases with (b)(4) (same batch number of the same suspect product, different patient, same reporter).This initial serious case report was received on 21-jun-2021 from a dentist by email via our sales representative.This case occurred with a (b)(6) male patient with an unspecified medical history, in (b)(6)2020, after the application of the suspected device biodentine (batch number #b22896b; expiry date: unk ) for a restorative treatment on tooth #33.The exact molecule of the anesthetic used for the dental procedure has not been stated.It was just indicated that it was a 1 / 200,000 anesthetic.In (b)(6) 2020, the patient complained of pain but nothing was apparent.X-ray showed a subgingival cavity on tooth #33, that the dentist could probe with a 17 probe or the end of a minick6 to pass under going.And there was a small flap.The dentist cleaned the cavity, filled it with biodentine and covered it with the skin flap.In (b)(6) 2020 the patient experienced gum pain.The dentist cleaned the necrotic gum, but there was an important gingival loss, which has completely exposed the area.Three months later, the gum had healed but remotely.The dentist covered biodentine with a composite.Toothache were resolved but the gum loss remained.Sender comment: causality assessment on (b)(6) 2021, on initial information received on (b)(6) 2021: seriousness: serious (other medically important condition).Expectedness: mucosal necrosis: unexpected (b)(6)/us.Gingival pain: unexpected (b)(6)/us.Gingival erosion: unexpected (b)(6)/us causality: latency - compatible.Recognized association - no.Analysis - in this case biodentine was placed in a dental cavity located under the gingiva, the procedure include: flap surgery and decay treatment.The patient experienced gum necrosis and loss, the route cause to consider for these events are: a traumatic /iatrogenic surgery that may have affected the gum hill, and the vasoconstrictor, often included in the local anesthetics that may have impaired the blood flow leading notably to the reported events in case of rapid injection.Therefore the causality with biodentine is assessed as unlikely.Dechallenge - na.Rechallenge - na.Concluded causality who: unlikely.

Manufacturer Narrative

Preliminary results and conclusion of manufacturer's investigation: the patient experienced gum necrosis and loss, unexpected for biodentine (biocompatible product).Batch and incident anteriority did not identify similar events with the batch number or similar incidents.The route cause to consider for these events are: -a traumatic /iatrogenic surgery (flap) that may have affected the gum hill, and -the vasoconstrictor, often included in the local anesthetics that may have impaired the blood flow leading notably to the reported events in case of rapid injection.Based on the preliminary analysis, and in the absence of anteriority on the batch and similar incidents, no capa is required.The case was submitted to fda on 05-jul-2021, however we received an email from fda on 30-sep-2021, that summary report box was checked and number of events (noe) was identified as >1 which as per fda is intended to capture reports submitted in summary format (voluntary malfunction summary reporting (vmsr) program).The email mentioned to re-submit the case with corrections.

Event Description

Spontaneous report, from france.Local reference: #(b)(4).Linked cases with #(b)(4) (same batch number of the same suspect product, different patient, same reporter).This initial serious case report was received on 21-jun-2021 from a dentist by email via our sales representative.This case occurred with a 51-year-old male patient with an unspecified medical history, in (b)(6) 2020, after the application of the suspected device biodentine (batch number #b22896b; expiry date: unk ) for a restorative treatment on tooth #33.The exact molecule of the anesthetic used for the dental procedure has not been stated.It was just indicated that it was a (b)(4) anesthetic.In (b)(6) 2020, the patient complained of pain but nothing was apparent.X-ray showed a subgingival cavity on tooth #33, that the dentist could probe with a 17 probe or the end of a minick6 to pass under going.And there was a small flap.The dentist cleaned the cavity, filled it with biodentine and covered it with the skin flap.In (b)(6) 2020 the patient experienced gum pain.The dentist cleaned the necrotic gum, but there was an important gingival loss, which has completely exposed the area.Three months later, the gum had healed but remotely.The dentist covered biodentine with a composite.Toothache were resolved but the gum loss remained.Sender comment: causality assessment on (b)(6) 2021, on initial information received on (b)(6) 2021: a.Seriousness: serious (other medically important condition) b.Expectedness: mucosal necrosis: unexpected fr/us.Gingival pain: unexpected fr/us.Gingival erosion: unexpected fr/us.C.Causality.A) latency - compatible.B) recognized association - no.C) analysis - in this case biodentine was placed in a dental cavity located under the gingiva, the procedure include: flap surgery and decay treatment.The patient experienced gum necrosis and loss, the route cause to consider for these events are: -a traumatic /iatrogenic surgery that may have affected the gum hill, and -the vasoconstrictor, often included in the local anesthetics that may have impaired the blood flow leading notably to the reported events in case of rapid injection.Therefore the causality with biodentine is assessed as unlikely.D) dechallenge - na.E) rechallenge - na.Concluded causality who: unlikely.The case was submitted to fda on 05-jul-2021, however we received an email from fda on 30-sep-2021, that summary report box was checked and number of events (noe) was identified as >1 which as per fda is intended to capture reports submitted in summary format (voluntary malfunction summary reporting (vmsr) program).The email mentioned to re-submit the case with corrections.

Event Description

Spontaneous report, from france.Local reference: # (b)(4).Linked cases with #(b)(4) (same batch number of the same suspect product, different patient, same reporter).This initial serious case report was received on 21-jun-2021 from a dentist by email via our sales representative.Follow-up 1 was received on 14-sept-2021 from qa in ennov.This case occurred with a 51-year-old male patient with an unspecified medical history, in (b)(6) 2020, after the application of the suspected device biodentine (batch number #b22896b; expiry date: oct-2020 for powder) for a restorative treatment on tooth #33.The exact molecule of the anesthetic used for the dental procedure has not been stated.It was just indicated that it was a 1 / 200,000 anesthetic.In (b)(6) 2020, the patient complained of pain but nothing was apparent.X-ray showed a subgingival cavity on tooth #33, that the dentist could probe with a 17 probe or the end of a minick6 to pass under going.And there was a small flap.The dentist cleaned the cavity, filled it with biodentine and covered it with the skin flap.In (b)(6) 2020 the patient experienced gum pain.The dentist cleaned the necrotic gum, but there was an important gingival loss, which has completely exposed the area.Three months later, the gum had healed but remotely.The dentist covered biodentine with a composite.Toothache were resolved but the gum loss remained.The batch of liquid dose contained in the box (batch b23281) was b22746, exp jun2020 but the dentist did not reported to have used this batch or another for the liquid.The company suspected a misuse since the liquid product was expired.Fup#1; received quality investigation report.Manufacturer's preliminary comments: the patient experienced gum necrosis and loss, the route cause to consider for these events are: -a traumatic /iatrogenic surgery that may have affected the gum hill, and -the vasoconstrictor, often included in the local anesthetics that may have impaired the blood flow leading notably to the reported events in case of rapid injection.Therefore the causality with biodentine is assessed as unlikely.Based on the preliminary analysis, and in the absence of anteriority on the batch and similar incidents, no capa is required.The case was submitted to fda on 05-jul-2021, however we received an email from fda on 30-sep-2021, that summary report box was checked and number of events (noe) was identified as 1 which as per fda is intended to capture reports submitted in summary format (voluntary malfunction summary reporting (vmsr) program).The email mentioned to re-submit the case with corrections.Manufacturer's final report: based on data from case report, and from quality investigations, no device quality defect was identified.Quality investigations were not performed on the returned product as it was expired when received.Therefore, a batch record review was made and it was within the specifiaction.The batch of liquid dose contained in the box used (batch b23281) was b22746 with expiry date jun2020.However, the dentist did not reported the batch number for liquid part, he only reported batch number for powder.Nevertheless, the company suspected a misuse since the liquid product was expired at the time of dental procedure.Product misuse is a probable root cause quality investigation report: no quality defect was observed during investigations.After investigation, no quality defects on device were observed for this complaint.A product misuse could be the root cause as it was suggested that the liquid part used during dental procedure was expired.The residual risk remains acceptable, a review of the risk assessment is not required.No device quality result was reported.The product used was probably expired and adverse events experienced could be related to the dental procedure.No corrective action is deemed necessary.Manufacturer final comments: no quality defect was detected.The dentist probably used an expired product (liquid part).No further field safety corrective action was conducted for safety reasons.

• Brand Name: BIODENTINE
• Type of Device: BIOACTIVE DENTAL SUBSTITUTE
• Manufacturer (Section D): SEPTODONT SAS; 58, rue du pont de creteil; saint maur, cedex val-de-marne 94100
• Manufacturer Contact: septodont s.a.s, artaud; 58 rue du pont de créteil; saint maur des fossess 94107 ; 3301497671
• MDR Report Key: 12116552
• MDR Text Key: 270271424
• Report Number: 9610964-2021-00016
• Device Sequence Number: 1
• Product Code: KIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Lot Number: B22896B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Male