iBur 8442-107-025DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327500813), received between Jan 9, 2024 and Jul 29, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 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.

• MalfunctionJul 29, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: FRACTURE. 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647339 ↗
• MalfunctionJan 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE THE HEAD OF THE BUR BROKE OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489622 ↗
• MalfunctionJan 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE WHILE DRILLING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479728 ↗