N/A 8470107030DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327097214), received between Apr 9, 2018 and Oct 21, 2024 — classified as 5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 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 20501225 ↗
• MalfunctionApr 28, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A SPINE PROCEDURE, THE BUR BROKE INSIDE THE ATTACHMENT. 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 11738757 ↗
• MalfunctionApr 28, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A SPINE PROCEDURE, THE BUR BROKE INSIDE THE ATTACHMENT. 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 11738754 ↗
• MalfunctionNov 15, 2018Break; Break

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC DISC REMOVING SURGERY 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 USING A BACKUP BUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073448 ↗
• MalfunctionApr 9, 2018Break; Break

  IT WAS REPORTED THAT WHEN PERFORMING SPINAL SURGERY, THE BUR BROKE INTO TWO PIECES. 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 7406471 ↗