AESCULAP GB520RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653069996), received between Nov 30, 2021 and Dec 6, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO AESCULAP AG THAT A HI-LINE CRANIOTOME HDPC W/O DURAGUARD (PART # GB520R) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE POWER SYSTEM MILLING CUTTER HANDLE (SN:(B)(4)) FAILED, AND THE SMALL STEEL BALL FELL OFF DURING USE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12939155 ↗
• MalfunctionNov 30, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GB520R - HI-LINE CRANIOTOME HDPC W/O DURAGUARD. ACCORDING TO THE COMPLAINT DESCRIPTION, THE STEEL BALL FELL OFF. WHEN CLEANING THE MILLING CUTTER HEAD, THE MEDICAL STAFF OF THE DISINFECTION CENTER FOUND THAT THE STEEL BALL IN THE BEARING OF THE MILLING CUTTER HANDLE FELL OFF AND THE BEARING INSIDE THE HANDLE WAS DAMAGED. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12901428 ↗