MAUDE Adverse Event Report: SEPTODONT SAS BIODENTINE

Lot Number UNKNOWN

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

Patient Problems Abscess (1690); Fistula (1862); Granuloma (1876); Osteolysis (2377)

Event Date 02/10/2020

Event Type  Injury  

Event Description

Spontaneous report, from belgium.Local reference # (b)(4).Afmps # (b)(4).Linked with local reference # (b)(4) (same reporter, same suspect product, same reported adr, different identifiable patient).Initial information received on 13-feb-2020 from dentist via dealer.Follow-up #1 information received on 23-feb-2020, follow-up #2 information received on 24-feb-2020 and follow-up #3 information received on 25-feb-2020 from dentist.All information are integrated in case narrative below.The dentist reported that a 10-year-old female patient, with unspecified medical history, had been treated with suspect device biodentine (batch #: b23279, expiration date: jun-2020) on (b)(6) 2019.The product was used for pulpotomy on milk and vital tooth.The patient was non-anxious before dental treatment.No concomitant drugs used.The dentist performed the following steps for the dental treatment: caries curettage, pulpotomy, disinfection, application of biodentine on the floor and at the entrance of the canals.On (b)(6) 2020, about 5 months after the product placement, the patient experienced dental fistula, an internal granuloma on distale root and bone loss (inter-radicular).The dentist performed actions for patient management: curettage, fistula disinfection, monitoring.According to the child's mother, her daughter had a dental abscess in the area of treated tooth, but not yet medically confirmed by the dentist.An interview was planned to follow patient's state.At the time of this report, the patient was not recovered.The evolution tended towards a premature loss of the tooth.No further information expected.No sample available for analysis from the reporter.Follow-up #1: additional information provided concerning patient's details, adrs, outcome (incident form completed).Follow-up #2: additional information provided concerning a correction of batch number.Follow-up #3: additional information provided new adr.Causality assessment on 12-mar-2020 by al on initial information received on 13-feb-2020 and on additional information received on 23-feb-2020, 24-feb-2020 and 25-feb-2020.A.Seriousness: serious (other medically important condition) due to the term dental fistula which is ime list.B.Expectedness: dental fistula: unexpected be.Apical granuloma: unexpected be.Bone loss: unexpected be.Tooth abscess: unexpected be.C.Causality a) latency - compatible.B) recognized association - no.C) analysis - this case describes a dental infection, with tooth abscess, apical granuloma, bone loss and dental fistula.This occurred 5 months after the treatment with biodentine for pulpotomy in a child patient so involving probable extensive caries.These effects are part of a clinical picture of multiple caries so may follow poor dental hygiene and tooth decay but also injury or previous surgery to teeth or gum.Therefore, considering chronology, possible pre-existing infection and possible injury during the dental process, the causal relationship between the reactions and biodentine was assessed as unlikely.No quality investigations could be performed, but as no other claims have been registered on the batch except 1 linked case reported by the same practitioner, no capa is required.D) dechallenge - na.E) rechallenge - na.Concluded causality who: unlikely.Following internal review, medical devices vigilance case reports have been updated with imdrf dictionary codes on 12-july-2021 manufacturer's initial comments: no sample available for analysis.Not available from the reporter.On initial information, pending quality investigations, as no other claims have been registered on the batch except 1 linked case reported by the same practitioner, no capa is required.Manufacturer's final comments: on final information, the causal relationship between the reactions and biodentine was assessed as unlikely.No quality investigations could be performed, but as no other claims have been registered on the batch except 1 linked case reported by the same practitioner, no capa is required.No sample available for analysis.Not available from the reporter.

Manufacturer Narrative

Manufacturer's initial comments: no sample available for analysis.Not available from the reporter.On initial information, pending quality investigations, as no other claims have been registered on the batch except 1 linked case reported by the same practitioner, no capa is required.Manufacturer's final comments: on final information, the causal relationship between the reactions and biodentine was assessed as unlikely.No quality investigations could be performed, but as no other claims have been registered on the batch except 1 linked case reported by the same practitioner, no capa is required.No sample available for analysis.Not available from the reporter.

• Brand Name: BIODENTINE
• Type of Device: BIODENTINE
• Manufacturer (Section D): SEPTODONT SAS; 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
• Manufacturer Contact: 58, rue du pont de creteil; saint maur, cedex val-de-marne, 94100
• MDR Report Key: 17631142
• MDR Text Key: 322247462
• Report Number: 9610964-2023-00014
• 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
• Report Date: 08/28/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 08/28/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 10 YR
• Patient Sex: Female