NA 78-40040Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · PEEK Customized Cranial Implant, XL · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327129250), received between Jan 15, 2020 and Mar 30, 2026 — classified as 2 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (8 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.
Reports received per month
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size8
- Adverse Event Without Identified Device or Use Problem1
- Device Handling Problem1
- Fitting Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Known Impact Or Consequence To Patient2
- Unspecified Infection1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE IMPLANT FIT VERY WELL ON THE POSTERIOR SIDE, BUT LEFT A SMALL GAP ON THE ANTERIOR SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729831 ↗MalfunctionMar 30, 2026Fitting Problem
IT WAS REPORTED THAT THE PEEK CRANIAL IMPLANT DID NOT FIT PROPERLY UPON PLACEMENT. A SURGICAL DELAY OF FIVE MINUTES WAS REPORTED. NO ADVERSE CONSEQUENCES OR ANY MEDICAL INTERVENTION WERE REPORTED AT INTAKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24728198 ↗MalfunctionDec 17, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THERE WAS A MINOR BUT ACCEPTABLE GAP ON THE POSTERIOR LEFT SIDE OF THE IMPLANT TO THE BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23827571 ↗InjuryNov 14, 2025Device Handling Problem; Device Handling Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23554098 ↗MalfunctionMay 27, 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 22091225 ↗MalfunctionMay 16, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PEEK IMPLANT DID NOT FIT PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22036766 ↗MalfunctionApr 25, 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 21908959 ↗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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21896069 ↗InjurySep 7, 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 WILL BE A REVISION SURGERY PERFORMED TO REPLACE THE IMPLANT.
Patient problems: Unspecified Infection
MAUDE report 17698543 ↗MalfunctionJun 15, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT A PEEK CUSTOMIZED IMPLANT DID NOT FIT TO THE PATIENT BONE AS EXPECTED. THE IMPLANT WAS BURRED DOWN AND REBUILT SO THAT IT COULD BE UTILIZED. NO ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10155497 ↗MalfunctionJan 15, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT THE CUSTOM-MADE IMPLANT WITH THE PATIENT'S 3D SCAN, LACKS SYMMETRY AND HAS AN UNAESTHETIC APPEARANCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9594293 ↗
Other Plate, cranioplasty, preformed, alterable devices
- OsteoMed 218-1604Osteomed LLC · Plate, cranioplasty, preformed, alterable1 recall6 reports
- OsteoMed 218-1604-SP-10Osteomed LLC · Plate, cranioplasty, preformed, alterable1 recall0 reports
- NA 56-90614Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable1 recall0 reports
- NA 78-50030Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable21 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 78-40030Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable9 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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