N/A 5820110020CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327294736), received between Aug 19, 2019 and Jul 29, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD IMAGING REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647038 ↗
• MalfunctionJun 5, 2025Detachment of Device or Device Component

  TIP OF THE 2.0MM CARBIDE ROUND DRILL BIT BROKE OFF DURING SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 22148958 ↗
• MalfunctionAug 19, 2019Break; Break

  IT WAS REPORTED THAT POST-OPERATIVELY, A FRAGMENT OF A BROKEN BUR WAS OBSERVED IN MRI IMAGES. IT WAS ALSO REPORTED THE FRAGMENT REMAINED IN THE PATIENT. 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 8905774 ↗