NA 0277010216Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04546540050502), received between Apr 19, 2018 and Apr 15, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (9 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113244 ↗
• MalfunctionJun 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOOTH EXTRACTION PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THAT THERE WAS A DELAY TO SURGERY TO OPEN AN ALTERNATIVE BUR. IT WAS ALSO REPORTED THAT THERE WAS NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653764 ↗
• MalfunctionDec 1, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A OSTEOPLASTY PROCEDURE, THE BUR BROKE AT THE TIP. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10929423 ↗
• MalfunctionOct 22, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE BUR BROKE DURING A TEETH EXTRACTION SURGERY. IT WAS FURTHER REPORTED THAT A SPARE BUR WAS USED TO COMPLETE THE SURGERY. 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 9220410 ↗
• MalfunctionAug 20, 2019Break; Break

  IT WAS REPORTED THAT TWO BURS BROKE AT THE CUTTING END DURING A TOOTH EXTRACTION. 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. THIS REPORT IS FOR THE SECOND BUR THAT BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8912767 ↗
• MalfunctionAug 20, 2019Break; Break

  IT WAS REPORTED THAT TWO BURS BROKE AT THE CUTTING END DURING A TOOTH EXTRACTION. 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. THIS REPORT IS FOR THE FIRST BUR THAT BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8912766 ↗
• MalfunctionMay 13, 2019Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON THE JAWBONE, THE BUR BROKE ALONG THE SHAFT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS 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 8604666 ↗
• MalfunctionNov 15, 2018Break; Break

  IT WAS REPORTED THAT DURING A DENTAL EXTRACTION PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THAT THE REPLACEMENT BUR ALSO BROKE. IT WAS FURTHER REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE FIRST BUR THAT BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073445 ↗
• MalfunctionNov 15, 2018Break; Break

  IT WAS REPORTED THAT DURING A DENTAL EXTRACTION PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THAT THE REPLACEMENT BUR ALSO BROKE. IT WAS FURTHER REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE SECOND BUR THAT BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073439 ↗
• MalfunctionOct 24, 2018Break; Break

  IT WAS REPORTED THAT DURING A DENTAL EXTRACTION SURGERY, THE BUR BROKE. IT WAS ALSO REPORTED THAT THE BROKEN FRAGMENT WAS REMOVED. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS 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 8001586 ↗
• MalfunctionSep 12, 2018Break; Break

  IT WAS REPORTED THAT DURING AN OSTEOTOMY PROCEDURE, THE BUR BROKE 3MM FROM THE CUTTING TIP. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS 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 7870448 ↗
• MalfunctionApr 19, 2018Break; Break

  IT WAS REPORTED THAT DURING MAXILLARY MANDIBULAR OSTEOTOMY, THE TIP OF THE BUR BROKE. 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 7443318 ↗