ELAN 4 US221Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046955073962), received between Mar 30, 2021 and Mar 30, 2021 — classified as 1 injury.

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

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2021Break; Break

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A BURR. THE DEVICE BROKE WHILE BEING USED IN A CRANIO-MAXILLOFACIAL SURGERY. THE FRAGMENT, WHICH HAD FALLEN IN THE SURGICAL FIELD, WAS REMOVED WITHOUT ANY HARM TO THE PATIENT. THERE WAS A FIVE MINUTE DELAY DUE TO THE REPORTED EVENT. ANOOTHER BURR WAS OPENED IN ORDER TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592120 ↗