TC cavity Burs Round E012334101200Recalls & reported problems
MAILLEFER INSTRUMENTS HOLDING Sàrl · Dental burs · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI J003E0123341012001), received between Nov 14, 2023 and Apr 17, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Sharp Edges1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Abrasion1
- Tissue Breakdown1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2026Break
IN THIS EVENT IT IS REPORTED THAT A CARBIDE BUR CAVITY ROUND FG012 BUR BROKE DURING USE. THE BROKEN PART FELL INTO THE PATIENT'S ORAL CAVITY. THE BROKEN PART WAS FOUND AND RETRIEVED PROMPTLY USING FORCEPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912734 ↗MalfunctionNov 13, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A CARBIDE BUR CAVITY ROUND FG012 BUR BROKE DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23542430 ↗InjuryNov 14, 2023Sharp Edges; Sharp Edges
IN THIS EVENT IT IS REPORTED THAT CARBIDE BUR CAVITY ROUND FG012 THAT WAS USED DURING TREATMENT REPORTEDLY THE SURFACE OF THE BUR WAS NOT SMOOTH. AFTER TREATMENT GINGIVAL BLEEDING WAS FOUND. HEMOSTASIS BY COMPRESSION WAS USED TO STOP THE BLEEDING. FURTHER INFORMATION REQUESTED.
Patient problems: Abrasion; Tissue Breakdown
MAUDE report 18130809 ↗
Other BUR, DENTAL devices
- Brasseler USA 001156T0Peter Brasseler Holdings, LLC · BUR, DENTAL1 recall0 reports
- TC cavity burs cone square E013834101200MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL7 reports
- NA 2296101421Stryker Corporation · BUR, DENTAL3 reports
- NA 1607002107Stryker Corporation · BUR, DENTAL3 reports
- NA 1607002105Stryker Corporation · BUR, DENTAL2 reports
- TC cavity Burs Round E012334101400MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL2 reports
- Zekrya® E014924101600MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL2 reports
- TC cavity Burs Round E012324101400MAILLEFER 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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