NA 78-50040Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07613327129274), received between Oct 9, 2018 and Jan 15, 2026 — classified as 7 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Inadequacy of Device Shape and/or Size

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24078758 ↗
• MalfunctionApr 24, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE IMPLANT WAS NOT LARGE ENOUGH TO FIT THE DEFECT AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900207 ↗
• MalfunctionApr 23, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE IMPLANT REQUIRED MAJOR ADJUSTMENT DUE TO CHANGES OF ANATOMY/CALCIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896010 ↗
• InjuryJan 31, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING THE SURGERY THE CUSTOM IMPLANT DID NOT FIT AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282611 ↗
• MalfunctionNov 22, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING THE SURGERY, THE PEEK IMPLANT SEEMED TO SIT HIGH AND WAS NOT AS FLUSH WITH THE NATIVE SKULL ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20757595 ↗
• MalfunctionOct 29, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE IMPLANT SHOULD HAVE COVERED THE WHOLE ENTIRE TEMPORAL BONE SECTION BUT HAS BEEN IMPLANTED SUCCESSFULLY. IT TURNED OUT THAT THE PREVIOUSLY MADE STATEMENT (DEVICE NEEDED TO BE CUT IN HALF) HAS BELONGED TO ANOTHER CASE AND WAS THEREFORE EVALUATED IN ANOTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558806 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO STRYKER THAT THE PATIENT EXPERIENCED POST OPERATIVE INFECTION AND A REVISION SURGERY WILL BE PERFORMED TO REMOVE AND REPLACE THE IMPLANT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 19977176 ↗
• InjuryOct 30, 2023Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 18035815 ↗
• MalfunctionJun 22, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE THE IMPLANT WAS SMALLER THAN EXPECTED AND THE CONTOUR WAS NOT AS EXPECTED. THERE WAS NO SIGNIFICANT SURGERY DELAY, NO REPORTED ADVERSE CONSEQUENCES AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17183205 ↗
• MalfunctionJun 22, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING THE PROCEDURE THE IMPLANT NEEDED TO BE BURRED DOWN DUE TO THE DEVICE NOT SITTING FLUSH WITH THE BONE. THERE WAS NO SIGNIFICANT SURGERY DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE EVENTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17183204 ↗
• MalfunctionNov 4, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING HE SURGERY, THE PEEK IMPLANT DID NOT FIT AS EXPECTED AND THE SURGEON HAD TO ALTER THE IMPLANT IN ORDER TO GET IT TO FIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15737150 ↗
• InjuryJun 21, 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 WAS NOT USABLE. A SECOND SURGERY WAS PERFORMED WITH A SECOND IMPLANT AND COMPLETED SUCCESSFULLY.

  Patient problems: Calcium Deposits/Calcification; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14757452 ↗
• MalfunctionMay 6, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING THE CRANIOPLASTY, THE SURGEON NOTICED THE PEEK IMPLANT COULD NOT BE PLACED ON THE BONE AS PLANNED. THE IMPLANT HAD THE RIGHT SHAPE, BUT IT WAS TOO THICK TO BE ABLE TO TOUCH THE PATIENT¿S BONE AND WAS RESTING ON THE BRAIN. SURGEON HAD TO INSTALL THE IMPLANT WITH THE OFFSET. THERE IS NO KNOWN POSTOPERATIVE DAMAGE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14308784 ↗
• MalfunctionApr 5, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT IT WAS NOTICED DURING A PROCEDURE, THE PEEK CCI WAS TOO LARGE AND NEEDED TO BE CUT DOWN TO FIT APPROPRIATELY.

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

  MAUDE report 14018263 ↗
• MalfunctionFeb 11, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE IMPLANT DIMENSIONS WERE INCORRECT AND DID NOT PROPERLY FIT THE PATIENT'S ANATOMY. THERE WAS A DELAY DURING SURGERY OF AROUND 2 HOURS, BUT NO ADVERSE CONSEQUENCES WERE REPORTED. THE IMPLANT WAS CUT INTO PIECES TO COMPLETE THE SURGERY.

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

  MAUDE report 13516761 ↗
• MalfunctionFeb 12, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT DURING THE CRANIOPLASTY, THE PEEK CRANIAL IMPLANT PLATE DID NOT FIT WELL. THE SURGEON HAD TO REMOVE BONE FROM THE SURGICAL SITE. THE SURGEON ALSO HAD TO DRILL DOWN AND THIN DOWN THE PLATE TO GET THE PLATE TO FIT . THE PLATE IS IMPLANTED AND NO OTHER INFORMATION IS KNOWN AT THIS TIME.

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

  MAUDE report 11325479 ↗
• InjuryJun 14, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A PEEK CCI WAS IMPLANTED, AND THEN FOLLOWING THE PROCEDURE THERE WAS DEHISCENCE. THE PATIENT ACQUIRED AN INFECTION. DURING THE REVISION SURGERY THERE WAS PUSS AROUND THE IMPLANT SIGHT, SO IT WAS REMOVED.

  Patient problems: Abscess; Unspecified Infection; Wound Dehiscence

  MAUDE report 8699987 ↗
• InjuryOct 9, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN IMPLANT WAS REMOVED DUE TO INFECTION. ANOTHER EXACT IMPLANT WAS MANUFACTURED TO REPLACE THE FIRST ONE.

  Patient problems: Unspecified Infection

  MAUDE report 7947235 ↗