TC cavity Burs Round E012324101400Recalls & reported problems
MAILLEFER INSTRUMENTS HOLDING Sàrl · Dental burs · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI J003E0123241014001), received between Mar 10, 2025 and Jul 1, 2026 — classified as 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2026Break
IN THIS EVENT IT IS REPORTED THAT A CARBIDE BUR CAVITY RND RA 014 BROKE DURING USE. THE BROKEN PART WAS RETRIEVED AND TREATMENT WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25678546 ↗MalfunctionMar 10, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A CARBIDE BUR CAVITY RND RA 014 BROKE DURING USE. THE OUTCOME OF PATIENT INJURY IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21563592 ↗
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
- TC cavity Burs Round E012334101200MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL3 reports
- NA 1607002107Stryker Corporation · BUR, DENTAL3 reports
- NA 2296101421Stryker Corporation · BUR, DENTAL3 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.
How reports and recalls are matched · Editorial policy · Report an error on this page