ELAN 4 GP453SURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964725999), received between Mar 17, 2022 and Mar 17, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2022Fracture; Fracture

  IT WAS REPORTED TO AESCULAP (B)(4) THAT AN ELAN 4 MIS L13 DISP.DIAMOND BURR D4.0 (PART # GP453SU) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE BAR WAS BROKEN. WHEN THIS PRODUCT WAS USED ON THE BASE OF THE SKULL, THREE CONSECUTIVE EVENTS OCCURRED THAT BROKE EVERY 10 MINUTES OF USE. USED FOR GA860 + GB927R. WHEN THE FIRST ONE WAS BROKEN, THE DOCTOR PRESSED THE TIP AGAINST THE BONE AND THOUGHT IT WAS THE CAUSE OF THE BREAK. THEREFORE, AFTER THAT, IT WAS USED WITH CARE NOT TO PRESS IT TOO MUCH, BUT IT BROKE WITH THE SECOND AND THIRD ONES. IT IS SAID THAT ALL THE BROKEN PARTS WERE ON THE GA860 SIDE FROM THE CENTER OF THE SHAFT. THERE WAS NO DESCRIBED PATIENT HARM. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AESCULAP (B)(4) REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13795203 ↗