ELAN 4 GP348RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964560385), received between Nov 16, 2021 and Nov 16, 2021 — classified as 1 injury.

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.

• InjuryNov 16, 2021Fracture; Fracture

  IT WAS REPORTED TO AESCULAP AG THAT A ELAN 4 2-RING TWIST DRILL D1.5 (PART # GP348R) WAS USED DURING A CRANIAL FORMATION PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE BAR BLADE WAS BROKEN. IN ORDER TO RESTORE THE SKULL FLAP OF THE AUTOLOGOUS BONE THAT HAD BEEN FROZEN, THE DOCTOR TRIED TO MAKE A HOLE BY ATTACHING A TWIST DRILL TO THE CRANIOTOME WHEN TENTING THE SKULL FLAP. HOWEVER, THE BAR WAS BROKEN. THE PHYSICIAN CONTINUED AND SUCCESSFULLY COMPLETED THE PROCEDURE USING A DIFFERENT DEVICE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820700 ↗