BIOROOT RCS 01E0300Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03760140703373), received between Jul 4, 2017 and Oct 23, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Extrusion” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 DE

  Patient problems: Necrosis; Swelling

  MAUDE report 6968516 ↗
• InjuryJul 4, 2017Extrusion; Extrusion

  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 INFORMATIO

  Patient problems: Tingling

  MAUDE report 6685396 ↗