NA 78-50030Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · PEEK Customized Cranial Implant Prio, L · Class 2 · Implant
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07613327129267), received between Aug 15, 2019 and Dec 1, 2025 — classified as 3 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (18 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.
Reports received per month
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size18
- Adverse Event Without Identified Device or Use Problem1
- Fitting Problem1
- Fracture1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Insufficient Information4
- Cerebral Edema3
- Failure of Implant1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Swelling/ Edema1
- Unspecified Infection1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 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 23680820 ↗MalfunctionSep 11, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23030874 ↗MalfunctionJul 10, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PEEK IMPLANT DID NOT FIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22467895 ↗MalfunctionMay 20, 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 CHANGE OF ANATOMY/CALCIFICATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22052307 ↗MalfunctionApr 23, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE IMPLANT REQUIRED SLIGHT ADJUSTMENTS DUE TO SOFT TISSUE INTERFERENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21896146 ↗MalfunctionApr 23, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE IMPLANT DID NOT FIT AT ALL DUE TO A CHANGE IN ANATOMY/CALCIFICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21896090 ↗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 CHANGES OF ANATOMY/CALCIFICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21896057 ↗MalfunctionJun 19, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT DURING SURGERY, IT WAS FOUND THAT THE IMPLANT DID NOT FIT AS EXPECTED. THE SURGEON HAD TO CUT THE IMPLANT TO HAVE IT FIT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19569365 ↗MalfunctionApr 12, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE STRYKER REPRESENTATIVE REPORTED THAT DURING THE PROCEDURE, IT WAS NOTICED THE POSTERIOR INFERIOR EDGE DID NOT FIT AS EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19095876 ↗MalfunctionDec 19, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT DURING REVIEW OF THE POST OPERATIVE PATIENT SCANS, THE SURGEON NOTICED THE IMPLANT APPEARS TO BE OUT FURTHER THAN THE CONTRA LATERAL SIDE OF THE PATIENTS HEAD AND THE SYMMETRY APPEARS TO BE OFF. NO OTHER INFORMATION IS KNOWN AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18358890 ↗MalfunctionDec 19, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT DURING THE PROCEDURE, THE IMPLANT DID NOT FIT AS EXPECTED. THE SURGEON HAD TO ALTER IT TO HAVE THE PROPER FIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18358718 ↗InjurySep 5, 2023Fitting Problem; Fitting Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON REALIZED THE IMPLANT DID NOT FIT THE AFFECTED AREA. THE IMPLANT WAS NOT USED TO COMPLETE THE SURGERY. THERE ARE NO FURTHER DETAILS AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17683014 ↗MalfunctionJan 25, 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 WAS MODIFIED TO FIT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16240389 ↗InjuryJan 18, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT DURING THE PROCEDURE, IT WAS NOTICED THAT THE IMPLANT DID NOT FIT AS EXPECTED. THE SURGERY WAS NOT COMPLETED SUCCESSFULLY AND A NEW IMPLANT IS TO BE DESIGNED AND A SECOND SURGERY TO BE PERFORMED.
Patient problems: Cerebral Edema; Failure of Implant
MAUDE report 16195417 ↗MalfunctionDec 15, 2022Inadequacy 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 MODIFIED TO BETTER FIT THE DEFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15992279 ↗MalfunctionSep 7, 2022Inadequacy 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 WAS MODIFIED TO FIT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Cerebral Edema; No Clinical Signs, Symptoms or Conditions
MAUDE report 15372674 ↗MalfunctionAug 13, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT THE CUSTOM IMPLANT DID NOT FIT PROPERLY. THE SURGERY WAS NOT COMPLETED AND IMPLANT WAS NOT USED. THERE IS NO OTHER INFORMATION KNOWN AT THIS TIME.
Patient problems: Insufficient Information; Swelling/ Edema
MAUDE report 12319899 ↗MalfunctionApr 28, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT DURING THE PROCEDURE THE IMPLANT WAS NOT FITTING AS EXPECTED AND IT WAS NOTICED THAT THE PATIENT HAD SWELLING OF THE BRAIN. THE CEREBROSPINAL FLUID WAS DRAINED AND IN ADDITION TO THIS, THE SURGEON CUT AND ADJUSTED THE IMPLANT TO FIT CORRECTLY. NO OTHER INFORMATION IS KNOWN AT THIS TIME.
Patient problems: Cerebral Edema; No Clinical Signs, Symptoms or Conditions
MAUDE report 11741249 ↗MalfunctionMar 30, 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 SO THE SURGEON SHAVED OFF 2-3MM OF THE IMPLANT AND IT DID NOT FIT STILL. THE SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER PRODUCT. NO OTHER INFORMATION IS KNOWN AT THIS TIME.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11590640 ↗MalfunctionFeb 7, 2020Nonstandard Device; Inadequacy of Device Shape and/or Size; Nonstandard Device; Inadequacy of Device Shape and/or Size
IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT A PATIENT PRESENTED WITH A GUN SHOT WOUND. IT WAS DECIDED THAT A PEEK PRIORITY IMPLANT WAS TO BE USED. THE SURGEON WAS PROVIDED TWO DESIGN OPTIONS. THE SURGEON CHOSE THE DESIGN HE FELT BEST FIT THE AREA/FRAGMENT. WHEN THE DEVICE CAME IN THERE WAS AN UNEXPECTED GAP IN THE FRONT. HE USED STANDARD PLATES TO BRIDGE THE GAP, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS DETERMINED THAT THIS WAS A DESIGN ISSUE AND THAT THE DEVICE WAS MANUFACTURED CORRECTLY ACCORDING TO THE DESIGN.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9683958 ↗InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT RECENTLY IMPLANTED CUSTOMIZED CRANIAL IMPLANT WAS BEING REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 8898335 ↗
Other Plate, cranioplasty, preformed, alterable devices
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- NA 56-90614Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable1 recall0 reports
- OsteoMed 218-1604-SP-10Osteomed LLC · Plate, cranioplasty, preformed, alterable1 recall0 reports
- THINFLAP SYSTEM 91-6704Biomet Microfixation, Inc · Plate, cranioplasty, preformed, alterable19 reports
- NA 78-50040Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable18 reports
- NA 78-10030Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable13 reports
- NA 78-40040Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable11 reports
- "1.5MM" SYSTEM 91-6104Biomet Microfixation, Inc · Plate, cranioplasty, preformed, alterable9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.