CRANIOPLATE FM921TRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04038653476527), received between Jun 4, 2021 and Feb 11, 2022 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FM921T - CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM. ACCORDING TO THE COMPLAINANT, DURING THE SKULL FIXATION PROCEDURE, THE SCREW WAS BROKEN. NO FRAGMENT REMAINED IN SITU. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. 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 13515808 ↗
• MalfunctionDec 3, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP AG THAT A CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM (PART # FM921T) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING STERILIZATION, THE DEVICE DISCOLORED AND BROKE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12927133 ↗
• MalfunctionDec 3, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP AG THAT A CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM (PART # FM921T) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SCREW WAS BROKEN. THE COMPLAINT DEVICE WAS NOT 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 AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924539 ↗
• MalfunctionDec 3, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP AG THAT A CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM (PART # FM921T) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SCREW WAS BROKEN. THE COMPLAINT DEVICE WAS NOT 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 AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924482 ↗
• MalfunctionDec 3, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP AG THAT A CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM (PART # FM921T) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SCREW WAS BROKEN. 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 AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924190 ↗
• MalfunctionDec 3, 2021Fracture; Fracture

  IT WAS REPORTED TO AESCULAP AG THAT A CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM (PART # FM921T) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SCREW WAS BROKEN. THE COMPLAINT DEVICE WAS NOT 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 AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923982 ↗
• MalfunctionDec 3, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP AG THAT A CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM (PART # FM921T) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SCREW WAS BROKEN. THE COMPLAINT DEVICE WAS NOT 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 AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12923963 ↗
• MalfunctionDec 2, 2021Break; Break

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FM921T - CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, NAIL BREAKAGE AND BURR OCCURRED. THE OPERATION TIME WAS PROLONGED AS A RESULT. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WAS SIGNIFICANT SURGERY DELAY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 12920812 ↗
• MalfunctionDec 2, 2021Break; Break

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FM921T - CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE DEVICE BROKE AND HAS BURRS. THIS MALFUNCTION PROLONGED THE SURGERY. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 12920758 ↗
• MalfunctionNov 7, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FM921T - CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SCREW WAS BROKEN. DURING THE OPERATION, NO OBVIOUS ABNORMALITY WAS FOUND WHEN THE NURSE UNPACKED THE COMPLETE SKULL CONNECTING PIECE AND SCREW. THE SURGEON PLACED THE CONNECTING PIECE ON THE SKULL ACCORDING TO THE NORMAL OPERATION PROCESS, AND THEN SCREW IT IN WITH SCREWS. IN THE PROCESS OF SCREWING IN, THE SCREW WAS BROKEN, AND THE SCREWED IN PART COULD NOT BE REMOVED AND SANK INTO THE SKULL. THE SURGEON IMMEDIATELY CHECKED THE PATIENT'S HEAD CONDITION AND CONFIRMED THAT THE BROKEN SCREW DID NOT FALL INTO THE PATIENT'S HEAD AFTER CAREFUL INVESTIGATION. THERE WAS SIGNIFICANT SURGERY DELAY. 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 12760383 ↗
• MalfunctionSep 10, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FM921T - CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THERE WAS SCREW BREAKAGE. THERE WERE BROKEN NAILS AND HAIRPINS DURING THE OPERATION, WHICH DELAYED THE DOCTOR'S OPERATION TIME. THERE WAS SIGNIFICANT SURGERY DELAY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12453926 ↗
• MalfunctionJul 19, 2021Fracture; Fracture

  IT WAS REPORTED TO AESCULAP AG THAT A CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM (PART # FM921T) WAS USED DURING A LEFT FRONTAL CRANIOTOMY AND INTRACRANIAL PRESSURE MONITORING TUBE IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE PATIENT UNDERWENT THE REMOVAL OF AN EPIDURAL HEMATOMA BY WAY OF A LEFT FRONTAL CRANIOTOMY PLUS THE IMPLANTATION OF AN INTRACRANIAL PRESSURE MONITORING TUBE DUE TO TRAUMATIC EPIDURAL HEMATOMA, LEFT TEMPORAL LOBE HEMORRHAGE, AND SKULL FRACTURE. REPORTEDLY, DURING THE PROCEDURE, THERE WAS NO OBVIOUS ABNORMALITY WHEN THE "NURSE TOOK APART THE SKULL CONNECTING PIECE AND SCREW WITH COMPLETE PACKAGE." ACCORDING TO THE NORMAL OPERATING PROCEDURE, THE PHYSICIAN PLACED "THE CONNECTING PIECE ON THE SKULL, AND THEN SCREWED IT IN." HOWEVER, WHILE ATTEMPTING TO DRIVE THE SCREW, IT BROKE. THE EMBEDDED PORTION OF SCREW WAS TRAPPED IN THE PATIENT'S SKULL, AND WAS NOT ABLE TO BE REMOVED. AT THAT TIME, THE SURGEON IMMEDIATELY CHECKED THE PATIENT'S HEAD CONDITION AND CONFIRMED THAT THE SCREW FRAGMENT HAS NOT DISLODGED INTO THE SURGICAL SITE. THE FRAGMENT REMAINED IN SITU. THE PROCEDURE WAS EXTENDED APPROXIMATELY FIFTEEN (15) MINUTES AS A RESULT OF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12189314 ↗
• InjuryJun 4, 2021Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FM921T-CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM. ACCORDING TO THE COMPLAINANT, WHILE REPAIRING THE SKULL, CRANIOPLATE SYSTEM WAS USED AND THREE (3) SCREWS REPEATEDLY BROKE. THE BROKEN TIP OF THE SCREWS REMAINED IN PATIENT'S SKULL. THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 11938785 ↗