NA 78-40020Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · PEEK Customized Cranial Implant, M · Class 2 · Implant
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327129335), received between Apr 1, 2022 and Dec 17, 2025 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 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 Size4
- Accessory Incompatible1
- Adverse Event Without Identified Device or Use Problem1
- Application Program Version or Upgrade Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Bacterial Infection1
- Unspecified Infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO NEW INFORMATION.
Patient problems: Bacterial Infection; Unspecified Infection
MAUDE report 23827565 ↗MalfunctionSep 15, 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 23050571 ↗InjuryFeb 21, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IMPLANT REQUIRED SLIGHT ADJUSTMENT. ADJUSTMENT TIME WAS 15MIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21432699 ↗MalfunctionDec 12, 2024Accessory Incompatible; Application Program Version or Upgrade Problem; Accessory Incompatible; Application Program Version or Upgrade Problem
THIS EVENT CONCERNS A PEEK SINGLE-STAGE PROCEDURE. AS PROVIDED DICOM DATA TURNED OUT TO BE INCOMPATIBLE WITH BRAINLAB DICOM IMAGES NEEDED TO BE RE-EXPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO MEDICAL INTERVENTION, SURGICAL DELAY OR ANY ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20913924 ↗MalfunctionDec 3, 2024Inadequacy 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 20829257 ↗MalfunctionApr 1, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT THE PEEK CCI DID NOT FIT AS EXPECTED. THERE IS NO OTHER KNOWN INFORMATION AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13973097 ↗
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- OsteoMed 218-1604-SP-10Osteomed LLC · 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 78-40040Stryker Leibinger GmbH & Co. KG · Plate, cranioplasty, preformed, alterable11 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.