CRANIOFIX® ABSORBABLE FF016Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04038653348398), received between Feb 11, 2021 and Jan 3, 2022 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2022Product Quality Problem; Product Quality Problem

  IT WAS REPORTED TO AESCULAP AG THAT A 6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM (PART # FF016) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPRING INSIDE OF THE HANDLE WAS NOT RELEASED DURING THE FINAL TIGHTENING OPERATION. REPORTEDLY, THE PRODUCT WAS DAMAGED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PATIENT HARM IS UNKNOWN. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 9610612-2021-00792 - 400538941, 9610612-2021-00793 - 400538942.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142136 ↗
• MalfunctionDec 20, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  CORRECTION/ADDITIONAL INFORMATION: PATIENT HARM CHANGED FROM ADDITIONAL MEDICAL INTERVENTION TO TEMPORARY IMPAIRMENT.

  Patient problems: Swelling/ Edema

  MAUDE report 13043692 ↗
• InjuryDec 20, 2021Unstable; Unstable

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FF016-6 CRANIOFIX ABSORBABL. CLAMP STERILE 11MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PATIENT UNDERWENT SURGERY IN (B)(6) 2020 AND WAS RE-FIXED WITH CFA IN (B)(6) OF THE SAME YEAR. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4) PATIENT INFO: (B)(6) GIRL.

  Patient problems: Failure of Implant

  MAUDE report 13043615 ↗
• InjuryDec 8, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IT WAS REPORTED TO AESCULAP AG THAT A 6 CRANIOFIX ABSORBABL.CLAMP STERILE 11MM (PART # FF016) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THREE (3) MONTHS AFTER THE SURGICAL PROCEDURE, THE SCALP JUST ABOVE THE CFA CONTRACTED AND BECAME THIN, AND EVENTUALLY THE SCALP WAS TORN. THE DOCTOR RE-SUTURED IN THE OUTPATIENT DEPARTMENT, HOWEVER, AFTER APPROXIMATELY A HALF YEAR, THE PATIENT WAS RE-SUTURED WITH GENERAL ANESTHESIA SURGERY. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION SURGERY 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 12960559 ↗
• MalfunctionDec 3, 2021Mechanics Altered; Mechanics Altered

  IT WAS REPORTED TO AESCULAP (B)(4) THAT A 6 CRANIOFIX ABSORBABL. CLAMP STERILE 11MM (PART # FF016) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PRODUCT WAS DAMAGED. IN PREPARATION FOR CRANIAL CLOSURE, THE PRODUCT LINE WAS BROKEN DURING PRE-TENSION. THE COMPLAINT DEVICE WAS 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 MALFUNCTION IS FILED UNDER (B)(4) REFERENCE CC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924149 ↗
• MalfunctionMay 7, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO AESCULAP AG THAT A CRANIOFIX ABSORBABL. CLAMP STERILE 11MM (PART # FF016) WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, SOME TISSUE PIECES COLLECTED AFTER REOPERATION OF PATIENTS USING CRANIOFIX ABSORBABLE. CRANIOFIX ABSORBABLE HAS BEEN ABSORBED, BUT INVESTIGATION OF THE TISSUE FRAGMENTS FORMED IN THE REMAINING SUTURE PART SHOULD BE INVESTIGATED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11793664 ↗
• MalfunctionApr 20, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FF016 - 6 CRANIOFIX ABSORBABL. CLAMP STERILE 11MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE WIRE BROKE DURING SURGERY. 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 11693287 ↗
• InjuryFeb 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FF016 - 6 CRANIOFIX ABSORBABL. CLAMP STERILE 11MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE DEVICE WAS DAMAGED IN THE LOWER DISC AND THE BONE FLAP WAS LIFTED, SO SURGERY WAS PERFORMED AGAIN. NO INFECTION. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314669 ↗