N/A 8470107525Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327097184), received between Jul 25, 2019 and Jan 22, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 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 18556915 ↗
• MalfunctionApr 28, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL 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 Consequences Or Impact To Patient

  MAUDE report 10004963 ↗
• MalfunctionJul 25, 2019Break; Break

  IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE DISCECTOMY THE DISTAL PORTION OF THE BUR BROKE OFF FROM THE DRILL ATTACHMENT WHILE THE SURGEON WAS DRILLING. IT WAS ALSO REPORTED THAT THE BROKEN PIECE WAS REMOVED USING IRRIGATION, AN X-RAY CONFIRMED THERE WERE NO OTHER FRAGMENTS IN THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WAS A DELAY OF FIVE MINUTES AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826343 ↗