MAUDE Adverse Event Report: SEPTODONT, INC. BIOROOT RCS

Model Number 01E0300

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Necrosis (1971); Swelling (2091)

Event Date 09/20/2017

Event Type  Injury  

Event Description

Spontaneous report, (b)(4).Initial information received on 21-sep-2017 from the dentist by phone.The dentist reported that a (b)(6) female patient, with medical history of allergy multiple, penicillin and aspirin allergy, dental fistula and broken tooth #21, received an unknown dose of the suspected septanest 40 mg/ml with adrenaline 1/200.000 solution for injection (articaine hydrochloride; epinephrine bitartrate), by dental route for local anaesthesia before a root canal procedure with the medical device bioroot rcs (batch b18997, exp 08/2018), on (b)(6) 2017.The patient had previously been treated with septanest 40 mg/ml with adrenaline 1/200.000, without complications.On (b)(6) 2017, at the end of dental procedure, the dentist noted a gingival swelling without inflammatory reaction (no redness), and the patient experienced soft tissue necrosis rather whitish appearance.During the root canal treatment, the dentist used a disinfectant (paroex) for cleaning the root, without reaction of the patient.The dentist confirmed there was no periapical extrusion of product.On (b)(6) 2017, the dentist saw again the patient and extension of swelling from cheek to eye was noted.The dentist removed the medical device bioroot rcs, and prescribed an anti inflammatory, flanid (tiaprofenic) and an homeopathic treatment with apis mellifica.Posology and therapy duration were not provided.At the time of this report, the patient was recovering.An interview was planned within 2 weeks.The dentist suspected an allergic reaction to the medical device bioroot rcs.Additional information received on 25-sep-2017 from the dentist by phone provided regarding patient's outcome, no periapical overfilling was done, and trade name of disinfectant used during dental treatment.Causality assessment on 29-sep-2017 on initial information received on 21-sep-2017: seriousness: serious (ime list term > other medically important condition).Listedness/expectedness: soft tissue necrosis: unexpected eu/us/ca; facial swelling: unexpected eu/us/ca.Gingival swelling: unexpected eu/us/ca.Causality: latency: suggestive, recognized association: no, analysis: in this case, swelling and local reaction occurred after the dental procedure.Swelling after root canal treatment is described, and these reactions are probably related to the endodontic procedure including shaping, canal irrigation and canal filling.However in this patient with medical history of multiple allergies, product hypersensitivity cannot be excluded.Moreover since patient recovered after removal of the cement, the causality between bioroot and facial and gingival swelling was assessed as possible.Regarding soft tissue necrosis, the local injection with vasoconstrictor may be an etiology but very few information is provided regarding this reaction and outcome was unknown.This must be a complication of dental fistula and abscess which seems the most probably etiology.Therefore, the causality between bioroot and soft tissue necrosis was assessed as unlikely.Dechallenge: na, rechallenge: na.Concluded causality who: unlikely for soft tissue necrosis, possible for facial swelling and gingival swelling.

• Brand Name: BIOROOT RCS
• Type of Device: BIOROOT RCS
• Manufacturer (Section D): SEPTODONT, INC.; 416 s. taylor avenue; louisville CO 80270
• Manufacturer (Section G): SEPTODONT INC.; 416 south taylor ave.; louisville CO 80027
• Manufacturer Contact: lawrence kass ; 416 south taylor ave.; louisville, CO 80027 ; 3036657535
• MDR Report Key: 6968516
• MDR Text Key: 89961904
• Report Number: 0001721729-2017-00010
• Device Sequence Number: 1
• Product Code: KIF
• UDI-Device Identifier: 03760140703373
• UDI-Public: 03760140703373
• Combination Product (y/n): Y
• PMA/PMN Number: K130601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 08/31/2018
• Device Model Number: 01E0300
• Device Lot Number: B18997
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2017
• Patient Sequence Number: 1
• Treatment: SEPTANEST 40 MG/ML ADRÉNALINÉE AU 1/200.000
• Patient Outcome(s): Other