iBur 8442-107-030DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327500806), received between Feb 14, 2024 and Apr 22, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31, 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954435 ↗
• MalfunctionApr 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE MILLING HEAD BROKE OFF DURING A CERVICAL SPINE PROCEDURE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS ALSO REPORTED THAT THE EVENT CONTRIBUTED TO A DELAY OF UNSPECIFIED DURATION. NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937241 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876061 ↗
• MalfunctionFeb 14, 2024Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE HEAD OF THE BUR BROKE. IT WAS ALSO REPORTED THAT THE EVENT CONTRIBUTED TO A 10 MINUTE DELAY. IT WAS FURTHER REPORTED THAT NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES OCCURRED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18703130 ↗