NA 78-10040Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540730794), received between Sep 28, 2018 and Jun 22, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (5 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.

• MalfunctionJun 22, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE IMPLANT DEMONSTRATED POOR FIT INTRAOPERATIVELY, WITH MISMATCHES BETWEEN ANTERIOR AND POSTERIOR REGIONS. SIGNIFICANT TRIMMING WAS REQUIRED IN THE ANTERIOR AND TEMPORAL AREAS; HOWEVER, A SLIGHT ANTERIOR GAP REMAINED. DESPITE AN OPTIMAL FIT IN THE DESIGN PLAN, THE IMPLANT APPEARED OVER BENT AND DID NOT MATCH INTRAOPERATIVE CONDITIONS.

  Patient problems: Insufficient Information

  MAUDE report 25580375 ↗
• MalfunctionApr 23, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE IMPLANT REQUIRED SLIGHT ADJUSTMENT DUE TO SOFT TISSUE INTERFERENCE.

  Patient problems: Cerebral Edema

  MAUDE report 21896191 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED WITH AN INFECTION AND THERE WAS A REVISION SURGERY PERFORMED TO REMOVE THE IMPLANT.

  Patient problems: Cerebrospinal Fluid Leakage; Unspecified Infection

  MAUDE report 17447166 ↗
• MalfunctionSep 7, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING THE PROCEDURE IT WAS FOUND THAT THE IMPLANT DID NOT FIT AS EXPECTED. THE IMPLANT WAS CUT DOWN AND MODIFIED TO FIT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15372660 ↗
• MalfunctionDec 1, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE IMPLANT DID NOT FIT CORRECTLY.

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

  MAUDE report 12910570 ↗
• MalfunctionOct 13, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE IMPLANT DID NOT FIT AS EXPECTED AND PORTIONS OF THE IMPLANT WERE CUT INTRA-OPERATIVELY IN ORDER TO IMPLANT THE DEVICE SUCCESSFULLY. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Swelling/ Edema

  MAUDE report 12626568 ↗
• InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT TWO WEEKS AGO A PATIENT UNDERWENT SURGERY. YESTERDAY, THE FLAP NEEDED TO BE REMOVED AS THE PATIENT HAD ACQUIRED AN INFECTION. THE INITIAL SURGEON IS UNAVAILABLE, SO HIS PARTNER PERFORMED THE REMOVAL, THE WOUND WASH OUT AND CLOSED UP THE PATIENT TO AWAIT THE INITIAL SURGEON'S RETURN AND SUGGESTED NEXT STEPS. THIS PATIENT HAS HAD 3 TUMORS REMOVED FROM THE SITE AS WELL AS A MINI SKIN GRAFT.

  Patient problems: Unspecified Infection

  MAUDE report 7986495 ↗
• MalfunctionSep 28, 2018Fitting Problem

  IT WAS REPORTED THAT THE CUSTOM IMPLANT DID NOT FIT THE WAY THE SURGEON WANTED. PER THE SURGEON, "IT WAS TOO FLAT". THE PROCEDURE WAS COMPLETED BY THE SURGEON BURRING DOWN THE POSTERIOR PORTION OF THE CCI TO REDUCE THE GAP AND TO CREATE A LESS PALPABLE SHAPE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7919658 ↗