NA 5820066012Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540362346), received between May 1, 2019 and Apr 4, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 5, 2024Open, Classified

   May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be considered a population at greatest risk.

   Z-0063-2025 · Root cause: Process control · FDA record ↗

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 4, 2023Fracture; Fracture

  IT WAS REPORTED VIA HEALTH CANADA REPORT REFERENCE #(B)(4), THAT DURING A SURGICAL PROCEDURE, THE DRILL BIT BROKE AT THE TIP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16672544 ↗
• MalfunctionDec 9, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A BSSO & LEFORT PROCEDURE, THE TIP OF THE BUR BROKE. THE FRAGMENT WAS IMMEDIATELY REMOVED FROM THE PATIENT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10979348 ↗
• MalfunctionDec 9, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A BSSO & LEFORT PROCEDURE, THE TIP OF THE BUR BROKE. THE FRAGMENT WAS IMMEDIATELY REMOVED FROM THE PATIENT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10979289 ↗
• MalfunctionMay 1, 2019Break; Break

  IT WAS REPORTED THAT PRIOR TO SURGERY, 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 Consequences Or Impact To Patient

  MAUDE report 8568819 ↗