TC cavity Burs Round E012324101600Recalls & reported problems
MAILLEFER INSTRUMENTS HOLDING Sàrl · Dental burs · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI J003E0123241016001), received between Jun 30, 2025 and Jun 30, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2025Break; Break
IN THIS EVENT A CARBIDE BUR CAVITY ROUND RA16 USED BROKE ON A PATIENT EXPERIENCED PAIN FOLLOWING A TREATMENT AND REPAIRED WITH CARIES, ROUTINE DISINFECTION OF IODOPHOR INTRAORAL AND EXTRAORAL, ROUTINE TOWEL LAYING, AND LOCAL INFILTRATION ANESTHESIA WITH 4% ARTICAINE. AFTER THE ONSET OF EFFECT, THE POSITIONING DRILL IS INCISED ALONG THE ALVEOLAR RIDGE CREST, THE FLAP IS TURNED OVER, THE CARIES TISSUE IS REMOVED, THE ENCAPSULATION IS RESTORED, AND THE RESIN MATERIAL IS FILLED AFTER 7 DAYS. THE SYMPTOMS WERE RELIEVED BY ANTI-INFLAMMATORY, ANALGESIC, AND DRESSING CHANGE IN THE HOSPITAL ON THE SAME DAY.
Patient problems: Pain
MAUDE report 22360675 ↗
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
- 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
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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