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); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Spontaneous report, from belgium.Agency reference id: (b)(4).Local reference # (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 28-feb-2020 from dentist.All information were integrated in case narrative below.The dentist reported that a 8-year-old female patient, had been treated with the suspect device biodentine (batch #: b23279, expiration date: jun-2020) for pulpotomy on vital tooth #54 (milk tooth) in (b)(6) 2019.At the end of 2019, the patient had a huge abscess, went to the emergency room and was hospitalized with antibiotics on an infusion for 2 days and the tooth was extracted.The dentist did not see the patient at this moment.The dentist never reported such a serious infectious problem after a pulpotomy she had performed.She decided to stop the use of the product in milk teeth and will continue to use it on definitive teeth.The dentist considered this case as serious.No further information expected.No sample available for analysis from the reporter.
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follow-up #1: incident form was received on 23-feb-2020 follow-up #2: dentist sent the correct batch number.Follow-up #3: dentist sent additional information (adr, patient data.).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 28-feb-2020.Re-evaluated on 11-sep-2020 by fl following internal review.A.Seriousness: serious (hospitalisation).B.Expectedness: tooth abscess: unexpected be.Tooth extraction: unexpected be.C.Causality: a) latency - compatible.B) recognized association - no.C) analysis - the pulpotomy procedure success depends on many factor: the correct indication and pulp status at the time of the treatment, the condition of procedure conduct and the control made periodically to avoid superinfection and situation such as dental abcess.In this case the patient experienced dental abcess with no further precising on pulp status, treatment and follow up visit.The causality of biodentine cannot be excluded and is assessed as possible.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: possible.On 11-sep-2020: assessment changed from unlikely to possible following internal review.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.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: 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.No investigation result available.

Manufacturer Narrative

Manufacturer's initial comments: no sample available for analysis.Not available from the reporter.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: 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.No investigation result available.

• 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: 17633445
• MDR Text Key: 322088715
• Report Number: 9610964-2023-00015
• 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): Hospitalization
• Patient Age: 8 YR
• Patient Sex: Female