CRANIOFIX2 FF490TRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04038653379576), received between Nov 13, 2020 and Jun 17, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2021Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED TO AESCULAP (B)(4) THAT A CRANIOFIX 2 TITANIUM CLAMP 11MM (PART # FF490T) WAS OPENED PRIOR TO USE. ACCORDING TO THE COMPLAINANT, THE PACKAGE GLUE WAS NOTED AS BEING TOO TIGHT CAUSING IT TO TEAR WHEN OPENED. THE REPORTER ALLEGED THAT THE PRODUCT DID NOT REMAIN STERILE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00461 ((B)(4)+ FF490T)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12021402 ↗
• MalfunctionJun 17, 2021Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED TO AESCULAP AG THAT A CRANIOFIX 2 TITANIUM CLAMP 11MM (PART # FF490T) WAS OPENED PRIOR TO USE. ACCORDING TO THE COMPLAINANT, THE PACKAGE GLUE WAS NOTED AS BEING TOO TIGHT CAUSING IT TO TEAR WHEN OPENED. THE REPORTER ALLEGED THAT THE PRODUCT DID NOT REMAIN STERILE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INVOLVEMENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00460 (B)(4) + FF490T).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12021323 ↗
• MalfunctionNov 13, 2020Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED TO AESCULAP AG THAT A CRANIOFIX 2 TITANIUM CLAMP 11MM (PART # FF490T) WAS TO BE USED DURING A NEUROSURGERY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE BLISTER PACK FROM THE SECOND PACKAGE WAS INCOMPLETE. THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED USING A REPLACEMENT DEVICE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE CC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10836494 ↗