NA 2296100212Recalls & reported problems
Stryker Corporation · 1.2mm Cross-Cut Fissure Carbide Bur · Class 1
Data updated Oct 13, 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 04546540045874), received between May 21, 2019 and May 23, 2022 — classified as 2 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE, THE BROKEN PIECE WAS RETRIEVED BY THE SURGEON FROM THE PATIENT¿S MOUTH. IT WAS ALSO REPORTED THAT THERE WAS AN UNKNOWN DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14470781 ↗MalfunctionMay 21, 2019Break; Break
IT WAS REPORTED THAT THE BUR BROKE DURING A MOLAR REMOVAL. IT WAS FURTHER REPORTED THAT THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8629557 ↗
Other BUR, DENTAL devices
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- NA 1607002107Stryker Corporation · BUR, DENTAL3 reports
- NA 2296101421Stryker Corporation · BUR, DENTAL3 reports
- TC cavity Burs Round E012334101200MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL3 reports
- NA 1607002105Stryker Corporation · 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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