BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIOH33.36.016 702 FGSURG BRIOCUT STERILE CARBIDE

    MDR report key: 14013475 · Received April 5, 2022

    Report

    Report Number
    1032227-2022-00002
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    March 8, 2022
    Report Date
    April 13, 2022
    Manufacturer
    PRIMA DENTAL GROUP
    Product Code
    EJL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING AN ORAL SURGERY, A BUR BROKE IN THE PATIENT'S MOUTH RESULTING IN LACERATING THE PATIENT'S TONGUE. THE DOCTOR THREW AWAY THE BUR AND WAS NOT SURE WHICH BUR WAS USED, EITHER BRIO H33.36.016 OR BRIO H33.36.021. NO OTHER INFORMATION HAS BEEN PROVIDED. OUT OF AN ABUNDANCE OF CAUTION, A REPORT IS BEING FILED FOR EACH BUR. THIS REPORT IS FOR BRIO H33.36.016. A SECOND REPORT (1032227-2022-00003) FOR BRIO H33.36.021 HAS ALSO BEEN SUBMITTED.

    Description of Event or Problem · 0

    A SURGICAL EXTRACTION OF TOOTH #12 (ROOT RESORPTION) WAS PERFORMED. LOCAL ANESTHETIC (B)(4) WAS USED. THE TOOTH WAS EXTRACTED WITH FORCEPS. REMAINING APICAL ROOT IN THE BONE WAS ELEVATED USING THE ROOT TIP ELEVATOR, BUT THE REMAINING ROOT KEPT BREAKING INTO PIECES AS IT WAS PARTIALLY RESORBED. AFTER TAKING MOST OF IT OUT, A VERY SMALL PORTION OF (3MM) APICAL TIP AREA WAS STILL IN THE BONE. AN ENDO FILE WAS USED TO TRY TO RETRIEVE IT, BUT WAS NOT SUCCESSFUL (ALTHOUGH IT WAS MOBILE). A SECOND DOCTOR (DR. SU) ATTEMPTED TO RETRIEVE IT WHO ALSO USED THE ROOT TIP ELEVATOR AND ENDO FILE, BUT WAS NOT SUCCESSFUL. BONE REMOVAL WAS ATTEMPTED USING THE SURGICAL HAND PIECE WITH SURGICAL BUR. THE PATIENT MOVED AND TURNED HIS HEAD INSTANTLY BECAUSE THE BUR BENT WITHIN THE SOCKET WHEN IT JUST BARELY TOUCHED THE BONE. THE PATIENT SWUNG HIS ARM AND TORSO AND CLOSED HIS JAW INSTANTLY, WHICH ENDED UP MAKING 2 SMALL CUTS ON HIS TONGUE. THE CUTS WERE NARROW BUT DEEP (APPROXIMATE SIZE. W= 1MM X L=2MM X H= UNDEFINED, BUT DEEPER THAN 2MM) ON VENTRAL AND DORSAL SURFACE OF THE TONGUE. PRESSURE WAS APPLIED IMMEDIATELY WITH STACKED 2 BY 2 GAUZE FOR 10-15 MINUTES. DR. SU WAS ABLE TO GET THE APICAL ROOT OUT WITH A ROOT TIP ELEVATOR. BLEEDING WAS CONTROLLED BOTH ON THE PATIENT'S TONGUE AND THE SOCKET. 3-0 GUT SUTURES WERE NOT USED. AFTER TREATMENT POST OPERATIVE INSTRUCTIONS WERE PRINTED AND GIVEN TO THE PATIENT. NO SMOKING, WATCH BLEEDING, NO HOT OR SHARP FOODS FOR 3-4 DAYS. INFORMED THE PATIENT THAT HE WILL DEVELOP ULCERS ON HIS TONGUE, AND THEY WILL BE SENSITIVE. AMOXICILLIN 500MG T.I.D. FOR 7 DAYS WAS PRESCRIBED AS THERE WAS SWELLING IN THE SOCKET AND THE TONGUE. ALSO, OVER THE COUNTER PAIN KILLERS (ADVIL AND TYLENOL) WERE RECOMMENDED FOR PAIN MANAGEMENT. THE PATIENT WAS MONITORED VIA PHONE CALL. THERE WERE NO COMPLICATIONS. THE DOCTOR THREW AWAY THE BUR AND WAS NOT SURE WHICH BUR WAS USED, EITHER BRIO H33.36.016 OR BRIO H33.36.021. OUT OF AN ABUNDANCE OF CAUTION, A REPORT WAS FILED FOR EACH BUR. THIS FOLLOW-UP REPORT IS FOR BRIO H33.36.016. A SECOND REPORT (1032227-2022-00003 FOLLOW-UP 1) FOR BRIO H33.36.021 HAS ALSO BEEN SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78760 BRIOH33.36.016 702 FGSURG BRIOCUT STERILE CARBIDE CARBIDE BUR EJL PRIMA DENTAL GROUP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Other