iBur 8431-013-050DCRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07613327501186), received between Sep 14, 2022 and Jan 23, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Fracture” (18 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jul 24, 2024Class IICompleted

   Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.

   Z-2729-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Fracture

  NO CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163722 ↗
• MalfunctionAug 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BUR BROKE AT THE CUTTING END. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAYS 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 20091022 ↗
• MalfunctionMay 22, 2024Fracture; Fracture

  PER MEDWATCH MW5153659; IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE BUR BROKE AND ALL BUR FRAGMENTS WERE RETRIEVED SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19375885 ↗
• MalfunctionFeb 20, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738148 ↗
• MalfunctionJan 22, 2024Fracture; 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 18556911 ↗
• InjuryOct 9, 2023Fracture; Fracture

  PER MEDWATCH REPORT#: MW5145184; IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THE EVENT CAUSED AN UNKNOWN SERIOUS INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894147 ↗
• MalfunctionSep 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A ANTERIOR CERVICAL DISCECTOMY AND FUSION(ACDF) SURGICAL PROCEDURE, THE BUR BROKE WHILE DRILLING. IT WAS ALSO REPORTED THERE WERE NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE EVENT CAUSED A 2 MINUTE DELAY TO THE PROCEDURE. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17731408 ↗
• MalfunctionJul 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO BURS BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS RECORD ADDRESSES ONE OF THE BUR BREAKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306814 ↗
• MalfunctionJul 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO BURS BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS RECORD ADDRESSES ONE OF THE BUR BREAKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306633 ↗
• MalfunctionJul 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO BURS BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS RECORD ADDRESSES ONE OF THE BURS THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305022 ↗
• MalfunctionJul 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO BURS BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS RECORD ADDRESSES ONE OF THE BURS THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305020 ↗
• MalfunctionJun 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE HEAD OF THE BUR BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS, 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 17159421 ↗
• MalfunctionJun 15, 2023Fracture; Fracture

  PER MEDWATCH REPORT#; MW5117493; IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT ALL PIECES OF THE BROKEN BUR WERE RETRIEVED SUCCESSFULLY. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134154 ↗
• MalfunctionApr 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT ALL PARTS OF THE BROKEN BUR WERE RETRIEVED SUCCESSFULLY FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16731681 ↗
• MalfunctionMar 29, 2023Fracture; Overheating of Device; Fracture; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR HEAD OVERHEATED AND BROKE. IT WAS ALSO REPORTED THERE WAS A SHORT DELAY AND NO ADVERSE CONSEQUENCES OR 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 16639634 ↗
• MalfunctionMar 29, 2023Vibration; Vibration

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR WAS VIBRATING. IT WAS ALSO REPORTED THAT THE EVENT CAUSED A SHORT DELAY AND NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635473 ↗
• MalfunctionSep 16, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO BURS 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. THIS RECORD ADDRESSES ONE INSTANCE OF THE BURS BREAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15441876 ↗
• MalfunctionSep 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE, IT WAS NOTED THAT THE BUR BROKE OUT OF THE PACKAGING. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417491 ↗
• MalfunctionSep 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 15417362 ↗