N/A 8450012030DCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327096842), received between Oct 23, 2018 and Jul 29, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2019Break; Break

  IT WAS REPORTED THAT DURING A CERVICAL SPINE PROCEDURE, THE BUR BROKE. 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 BACK-UP BUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8836663 ↗
• MalfunctionOct 23, 2018Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A SPINAL SURGERY, TWO BURS TWISTED AND BROKE. IT WAS ALSO REPORTED THAT THERE WAS A FIFTEEN MINUTE DELAY TO CHANGE BURS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE FIRST BUR THAT BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7997262 ↗
• MalfunctionOct 23, 2018Break; Break

  IT WAS REPORTED THAT DURING A SPINAL SURGERY, TWO BURS TWISTED AND BROKE. IT WAS ALSO REPORTED THAT THERE WAS A FIFTEEN MINUTE DELAY TO CHANGE BURS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE SECOND BUR THAT BROKE. IT WAS SUBSEQUENTLY DETERMINED UPON EVALUATION OF THE RETURNED DEVICES, THAT ONLY 1 BUR BROKE AND 1 BUR WAS BENT. THIS REPORT IS FOR THE BUR THAT BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7994948 ↗