iBur 8442-107-525Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327500257), received between Nov 11, 2022 and Dec 6, 2023 — classified as 2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP OF THE BUR BROKE IN THE PATIENT WHICH WAS QUICKLY RETRIEVED. IT WAS ALSO REPORTED THAT THE EVENT CONTRIBUTED TO A DELAY OF 60-120 MINUTES. IT WAS FURTHER REPORTED THAT NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION 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 18275602 ↗
• MalfunctionNov 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A MICRO DISC SURGICAL PROCEDURE, IT WAS NOTED THAT THE HEAD OF THE BUR BROKE INSIDE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15779587 ↗