TC cavity burs cone square E013834101200Recalls & reported problems
MAILLEFER INSTRUMENTS HOLDING Sàrl · Dental burs · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI J003E0138341012001), received between Jul 17, 2024 and Jun 24, 2026 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Break” (7 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break7
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Device Embedded In Tissue or Plaque2
- Insufficient Information2
- Laceration(s)2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2026Break
IN THIS EVENT IT IS REPORTED THAT A CARB.B.CAV.CONE SQUARE FG 012 BUR BROKE DURING USE AND COLLAPSED ONTO THE PATIENT'S TONGUE, CAUSING THE PATIENT TO BLEED. THE DOCTOR APPLIED PRESSURE HEMOSTASIS ON THE PATIENT AND PERFORMED FOLLOW UP TREATMENT AFTER THE PATIENT HAD NO DISCOMFORT. NO INJURY.
Patient problems: Laceration(s)
MAUDE report 25609776 ↗InjuryDec 4, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A CARB.B.CAV.CONE SQUARE FG 012 BUR THAT WAS USED IN THE TREATMENT OF A PATIENT DAMAGED SOFT TISSUE OF THE PATIENT'S LATERAL EDGE OF THEIR TONGUE DURING USE OF THE BUR. REPORTEDLY, THIS LEAD TO AN ULCERATION THAT WAS TREATED WITH IODINE GLYCERIN. FURTHER INFORMATION REQUESTED.
Patient problems: Laceration(s)
MAUDE report 23716272 ↗MalfunctionNov 12, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A CARB.B.CAV.CONE SQUARE FG 012 BUR BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23532952 ↗MalfunctionOct 22, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A CARB.B.CAV.CONE SQUARE FG 012 BUR BROKE DURING USE. REPORTEDLY, NO INJURY BUT THE OUTCOME IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 23356686 ↗MalfunctionOct 22, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A A CARB.B.CAV.CONE SQUARE FG 012 BUR BROKE DURING USE. REPORTEDLY, NO INJURY BUT THE OUTCOME IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 23356634 ↗MalfunctionJun 16, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A CARB.B.CAV.CONE SQUARE FG 012 BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. REPORTEDLY, THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22210468 ↗MalfunctionJul 17, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A CARB.B.CAV.CONE SQUARE FG 012 BROKE DURING USE. REPORTEDLY, UNBEARABLE PAIN WAS CAUSED TO THE PATIENT. THE OUTCOME IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19762486 ↗
Other BUR, DENTAL devices
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- NA 2296101421Stryker Corporation · BUR, DENTAL3 reports
- TC cavity Burs Round E012324101400MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL2 reports
- NA 2296100212Stryker Corporation · BUR, DENTAL2 reports
- TC cavity Burs Round E012334101400MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL2 reports
- Zekrya® E014924101600MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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