N/A 8450009030Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327096804), received between Oct 24, 2018 and Apr 2, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Fracture

  IT WAS REPORTED THAT A BROKEN BUR WAS FOUND INSIDE THE ATTACHMENT AT THE USER FACILITY. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764869 ↗
• MalfunctionOct 22, 2024Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 1 EVENT HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20501489 ↗
• MalfunctionFeb 24, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DEVICE OVERHEATED AND THE BUR BROKE IN THE ATTACHMENT. IT WAS ALSO REPORTED 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 RECORD ADDRESSES THE INSTANCE OF THE BUR BREAKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9745669 ↗
• MalfunctionMar 6, 2019Break; Break

  IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE SPINE SURGICAL PROCEDURE, THE BUR BROKE IN THE ATTACHMENT. IT WAS ALSO REPORTED THERE WERE A 10 MINUTE DELAY. IT WAS FURTHER REPORTED THAT NO ADVERSE CONSEQUENCES OCCURRED 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 8395355 ↗
• MalfunctionOct 24, 2018Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED 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 8001588 ↗