NA 1607002107Recalls & reported problems
Stryker Corporation · 1.6mm Taper Side Cutting Carbide Bur · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540466495), received between May 7, 2021 and Jul 29, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2025Fracture; Fracture
THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FRACTURE. 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22647431 ↗MalfunctionNov 8, 2021Fracture; Fracture
PER MEDWATCH (B)(4) IT WAS REPORTED THAT DURING A LEFORT I MAXILLARY ADVANCEMENT, BILATERAL SAGITTAL SPLIT OSTEOTOMY, MANDIBULAR ADVANCEMENT SURGERY, THE TIP OF THE BUR BROKE OFF IN THE BONE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE WAS RETRIEVED. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12773334 ↗MalfunctionMay 7, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11789884 ↗
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
- TC cavity Burs Round E012334101200MAILLEFER INSTRUMENTS HOLDING Sàrl · BUR, DENTAL3 reports
- NA 2296100212Stryker Corporation · BUR, DENTAL2 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.