MAUDE Adverse Event Report: SEPTODONT, INC. BIOROOT RCS

Model Number 01E0300

Device Problem Extrusion (2934)

Patient Problem Tingling (2171)

Event Date 05/06/2017

Event Type  Injury  

Event Description

(b)(4).Initial information received on (b)(6) 2017 and additional information received on 11-may-2017 and (b)(6) 2017: on (b)(6) 2017 the dentist reported that he performed a root canal procedure on 2nd premolar on mandibular side on a patient with the medical device bioroot.He reported that the medical device extruded reaching the mandibular nerve and leading to lip paresthesia.On 11-may-2017, the dentist reported additional information.The patient was a (b)(6) male, with no specific medical history, who had already been treated by this dentist.The dentist confirmed that he performed dental procedure on tooth #45.He performed a troncular injection of 1/2 cartridge of scandonest 30mg/ml (mepivacaine hydrochloride) (batch number unknown) for anesthesia but this product was not suspected in this report.He used sodium hipochloride 5/25 as root canal irrigant.He performed an x-ray to check : cone was in place, and no extrusion was observed.The patient experienced lip paresthesia, so the dentist performed a scan.An extrusion of the device was observed.The device extruded and reached the external branch of the mandibular nerve.On (b)(6) 2017, the dentist reported some additional information.The patient went to see a maxillo-facial surgeon.The dentist was supposed to see the patient after that.Additional information was expected.Additional information received on 18-may-2017 by phone.The patient was referred to a maxilo-facial surgeon on (b)(6) 2017 for bioroot cement extrusion by removal.The surgery was performed under generalized anesthesia.No information on the patient's status after surgery was provided.At the time of this report, the patient's outcome was unknown.Further information was expected.Additional information received on 08-jun-2017.The dentist saw the patient on (b)(6) 2017 and performed a new scan to check what the surgeon did about product extrusion.The product was taken off the apex but was still present around the nerve (white stripe visible on the scan).The dentist asked the patient to go see the surgeon once again to know why he did not remove the whole product.The patient was still suffering from lip paraesthesia.Causality assessment on 19-may-2017 on initial information received on (b)(6) 2017 and additional information received on 11-may-2017, (b)(6) 2017 and 18-may-2017: seriousness: serious (other medically important condition and required intervention to prevent permanent impairment/damage).Expectedness: paresthesia oral: unlisted eu, unexpected fr; device extrusion: unlisted eu, unexpected fr.Causality: latency: possible.Recognized association: no.Analysis: lip paraesthesia may be due to dental procedure which may had caused direct nerve trauma or to chemical toxicity of irrigation solution.Lip paraesthesia may also be due to compression of the nerve caused by hematoma, by oedema following the dental procedure or by the overfilling spreading of bioroot.In this case, the dentist reports an extrusion of bioroot.The scanner confirms the compression of the external branch of the mandibular nerve.Therefore, the causal relationship between bioroot and paraesthesia is related to the dental procedure with extrusion of the cement and lead to nerve compression.Dechallenge: na.Rechallenge: na.Concluded causality who: probable.Causality assessment on 13-jun-2017 on additional information received on 08-jun-2017: seriousness: serious (other medically important condition and required intervention to prevent permanent impairment/damage).Expectedness: paresthesia oral: unlisted eu, unexpected fr; device extrusion: unlisted eu, unexpected fr.Causality: latency: possible.Recognized association: no.Analysis: the patient still suffers from the paresthesia of the lip because the paste is still present around the branch of the mandibular nerve confirmed by the scanner performed by the dentist.Therefore, the previous assessment applies.Dechallenge: na.Rechallenge: na.Concluded causality who: probable.

Manufacturer Narrative

In view no device was returned for evaluation, the production record for the reported suspect device batch was reviewed; no issue identified.The reported batch number was distributed to the following countries: (b)(4).No other complaint has been received for the reported batch number.

Event Description

Additional information received on (b)(4) 2017: the dentist reported the batch number of bioroot was (b)(4).He stated that he has used bioroot several times before on several patients.The dentist saw the patient again on (b)(6) 2017.He reported that the surgeon did not remove the product which was close around the nerve as he thought it was not necessary.The patient had recovered from numbness of lips and chin.Causality assessment on (b)(4) 2017 on additional information received on (b)(4) 2017: seriousness: serious (other medically important condition and required intervention to prevent permanent impairment/damage).Expectedness: paresthesia oral: unlisted eu, unexpected fr, device extrusion: unlisted eu, unexpected fr, causality: latency: possible.Recognized association: no.Analysis: lip paraesthesia may be due to dental procedure considering possible direct nerve trauma, chemical toxicity of irrigation solution or compression of the nerve caused by hematoma, oedema or overfilling spreading of bioroot.In this case, the dentist reported bioroot extrusion, and compression of the external branch of the mandibular nerve was confirmed by scan.According to the last information, the product was removed from the apex by the surgeon but was still present around the nerve.The patient recovered from numbness of lips and chin on unknown date.Therefore this may have play a role in patient recovery.However, as the product has not been completely removed, paraesthesia may be related to the dental procedure with extrusion of the cement which led to nerve compression.Therefore, the causal relationship between bioroot and paraesthesia was assessed as possible, dechallenge: na.Rechallenge: na.Concluded causality who: possible.

• 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: 6685396
• MDR Text Key: 79029256
• Report Number: 0001721729-2017-00006
• Device Sequence Number: 1
• Product Code: KIF
• UDI-Device Identifier: 03760140703373
• UDI-Public: 03760140703373
• Combination Product (y/n): N
• 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,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: 01E0300
• Device Lot Number: B18997
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 23 YR