CONMED 00137501200Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10845854012338), received between Nov 16, 2018 and Dec 12, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Overheating of Device” (3 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2025Overheating of Device; Overheating of Device

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE (B)(6), BUR GUARD, MEDIUM WAS BEING USED DURING A WISDOM TEETH EXODONTIA ON (B)(6) 2025 AND ¿HIGH SPEED DRILL AND BUR GUARD MADE RATTLING SOUND MID PROCEDURE, SO THE BUR GUARD WAS SWAPPED FOR A NEW UNIT AND TESTED FOR FUNCTION. PROCEDURE RESUMED. DRILL AND BUR GUARD GOT HOT IMMEDIATELY AND CAUSED BURN TO PATIENTS LIP AND SURGEONS HAND¿ THE DEGREE OF THE BURN WAS NOT ASSESSED OR RECORDED. THERE IS A PHOTO AVAILABLE UPON REQUEST. PATIENT INJURY: LOWER LIP AND VERMILLION BORDER, RIGHT HAND SIDE - BURNED, SIZE OF AREA =2CM. USER/SURGEON INJURY: RIGHT INDEX FINGER AND WEBBING BETWEEN RIGHT INDEX FINGER AND RIGHT THUMB MILD BURN. THE PATIENT'S TREATMENT WAS: SURGEON IRRIGATED PATIENT'S LIP WITH SALINE, AND SIGMACORT WAS APPLIED. SURGEON COMPLETED REVIEW APPOINTMENTS TO MONITOR THE HEALING PROCESS. NO TREATMENT FOR THE SURGEON'S HAND.¿ THE PHOTO WAS REQUESTED AND TO DATE HAS NOT BEEN RECEIVED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH ALL 4 WISDOM TEETH EXTRACTED AND THERE WAS A 5-MINUTE DELAY. THE PRO7000SE, HALL MICROPOWER+ HIGH SPEED DRILL WILL BE LISTED AS A CONCOMITANT DEVICE AND THERE IS NO ALLEGATION AGAINST IT.

  Patient problems: Burn(s)

  MAUDE report 23788104 ↗
• InjuryApr 19, 2023Overheating of Device; Overheating of Device

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 00137501200, BUR GUARD, MEDIUM WAS BEING USED ON (B)(6) 2023 DURING A TEETH REMOVAL PROCEDURE AND ¿A BUR GUARD OVERHEATED AND CAUSED INJURY TO THE PATIENT¿S LIP, THE EXTENT IS YET TO BE DETERMINED. WHEN PLACED ON THE DRAPE IT MELTED ONTO THE BUR GUARD ITSELF. THE SURGEON FELT NO HEAT RADIATION INTO THE HANDPIECE. THE BUR WAS EASILY REMOVED AS WAS THE BUR GUARD¿. THE PROCEDURE WAS COMPLETED AND THERE WAS NO DELAY. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO UNKNOWN DEGREE OF BURN TO THE PATIENT¿S LIP.

  Patient problems: Burn(s)

  MAUDE report 16770486 ↗
• InjuryApr 18, 2019Excessive Heating; Excessive Heating

  ON BEHALF OF THE CUSTOMER THE CONMED REPRESENTATIVE REPORTED ISSUES WITH THE HALL ORALMAX ELITE HIGH SPEED DRILL, ITEM # PRO7000DE, SERIAL (B)(4) AND THE BUR GUARD, MEDIUM, ITEM # 00137501200, LOT# 983015 THAT OCCURRED DURING A MOLAR EXTRACTION ON (B)(6) 2019. IT WAS REPORTED THAT "DURING MOLAR EXTRACTION ON (B)(6) 2019, THE UNIT BECAME VERY HOT AND BURNED A PATIENT'S LIP. PATIENT LIP BLISTERED." ADDITIONAL INFORMATION OBTAINED INDICATES THAT THE DRILL & BUR GUARD HAD BEEN IN USE FOR 15-20 MINUTES. THE DOCTOR SECTIONED AND REMOVED TOOTH #17 WITH NO DRILL ISSUES AND WAS STARTING THE REMOVAL OF #32 WHEN THE ISSUE OCCURRED. THE DOCTOR WAS SECTIONING TOOTH #32 TO REMOVE WHEN THE DRILL OVERHEATED CAUSING AN ABRASION TO PATIENT'S LOWER RIGHT LIP ADJACENT TO PREMOLAR AREA. A 5MM DIAMETER BLISTER WAS NOTED. NO SUTURE WAS NEEDED, THERE WAS NO ADDITIONAL MEDICAL INTERVENTION AND THE PATIENT'S LIP / BURN WAS TREATED WITH A THIN LAYER OF VASELINE. THE PATIENT IS REPORTED TO BE WELL AT THIS TIME AND HAS NOT RETURNED FOR TREATMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER HALL DRILL WITH NO REPORTED DELAY. THE BUR GUARD, MEDIUM, ITEM # 00137501200 LOT#983015 WILL BE REPORTED ON AS

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8527700 ↗
• InjuryNov 16, 2018Overheating of Device; Overheating of Device

  THE CUSTOMER REPORTED THAT 00137501200, BUR GUARD, MEDIUM, DEVICE BURNED A PATIENT LIP DURING AN ORAL SURGERY PROCEDURE. FURTHER INFORMATION WAS REQUESTED FROM THE REPORTING ACCOUNT; HOWEVER, TO DATE NO FURTHER INFORMATION HAS BEEN RECEIVED. A GOOD FAITH EFFORT WAS ATTEMPTED TO GAIN FURTHER INFORMATION. THE PATIENT WAS REPORTED AS INJURED BUT THE DEGREE OF BURN IS UNKNOWN. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY.

  Patient problems: Burn(s)

  MAUDE report 8077848 ↗