NA 78-10030Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04546540730787), received between Apr 12, 2019 and Jun 11, 2026 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE POSTERIOR SEGMENT OF THE IMPLANT WAS ELEVATED BY APPROXIMATELY 8 MM, AND INTRAOPERATIVE MODIFICATIONS (CUTS) WERE MADE TO IMPROVE THE IMPLANT FIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25468444 ↗
• MalfunctionSep 2, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937066 ↗
• MalfunctionApr 24, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE IMPLANT REQUIRED MODERATE ADJUSTMENT DUE TO A COMPROMISED IMPLANT DESIGN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900206 ↗
• MalfunctionApr 23, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE IMPLANT REQUIRED MODERATE ADJUSTMENT DUE TO SOFT TISSUE INTERFERENCE AND A COMPROMISED IMPLANT DESIGN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896088 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PERFORMED A REVISION SURGERY TO REMOVE THE IMPLANT DUE TO PATIENT CONDITION. THERE WILL BE ANOTHER SURGERY PERFORMED AT A LATER DATE TO REPLACE THE IMPLANT THAT WAS REMOVED.

  Patient problems: Bacterial Infection

  MAUDE report 18142402 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE A REVISION SURGERY WAS PERFORMED TO REMOVE THE IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 17551032 ↗
• MalfunctionApr 5, 2023Inadequacy 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 THE IMPLANT HAD TO BE CUT IN THE POSTERIOR SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682826 ↗
• MalfunctionAug 15, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PEEK IMPLANT DID NOT FIT AS EXPECTED AND NEEDED TO BE MODIFIED TO COMPLETE THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 15225708 ↗
• MalfunctionJul 11, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PEEK IMPLANT DID NOT FIT AS EXPECTED AND NEEDED TO BE MODIFIED TO COMPLETE THE SURGERY.

  Patient problems: Calcium Deposits/Calcification; Insufficient Information

  MAUDE report 14981159 ↗
• MalfunctionJan 14, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT THE IMPLANT DID NOT FIT CORRECTLY AND SURGERY WAS NOT COMPLETED. THE PATIENT WILL REQUIRE A NEW IMPLANT.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11169810 ↗
• MalfunctionOct 9, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT THE FIT OF THE CCI WAS NOT AS INTENDED TOWARDS THE FRONTAL BONE REGION. THE IMPLANT WAS BURRED DOWN AND ULTIMATELY USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10655858 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THERE WAS AN INFECTION AFTER IMPLANTATION OF A PLATE. THE SURGEON PLANS TO REMOVE AND REPLACE THE IMPLANT. THERE WAS NO MENTION OF PRODUCT FAILURE/MALFUNCTION.

  Patient problems: Unspecified Infection

  MAUDE report 9934743 ↗
• InjuryApr 12, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT AFTER IMPLANTING A PEEK IMPLANT, THE PATIENT ACQUIRED AN INFECTION AND THE DEVICE WAS REMOVED. THE FACILITY DISCARDED THE FLAP IN THE OR AND REVISION SURGERY IS PLANNED.

  Patient problems: Unspecified Infection

  MAUDE report 8509980 ↗