NA 78-10010Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · PEEK CUSTOMIZED CRANIAL IMPLANT KIT, S · Class 2 · Implant
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540730763), received between Jun 19, 2019 and Oct 2, 2025 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (5 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 Size5
- Adverse Event Without Identified Device or Use Problem1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Post Operative Wound Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 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 23199403 ↗MalfunctionSep 11, 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 23030897 ↗MalfunctionApr 23, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT IT WAS NOTICED DURING SURGERY, WHEN THE IMPLANT WAS PLACED, THERE WAS A GAP PRESENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19163697 ↗MalfunctionJul 26, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED DURING THE SURGERY THAT THE IMPLANT DID NOT FIT AS EXPECTED; IT WAS TOO THICK AND DID NOT FIT FLUSH. THE SURGEON ENDED UP BURRING DOWN THE IMPLANT AND USED IT TO COMPLETE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17397545 ↗InjuryJun 7, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON NOTICED THE IMPLANT WAS NOT THE ACCURATE SIZE (TOO SMALL) AND THE IMPLANT WAS NOT USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17080764 ↗MalfunctionApr 18, 2023Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE PEEK IMPLANT DID NOT FIT AS EXPECTED, IT WAS TOO LARGE. THE SURGEON NEEDED TO MODIFY THE IMPLANT TO FIT THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO SURGERY DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16762144 ↗InjuryJun 19, 2019Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT A REVISION SURGERY OCCURRED RELATED TO A POST-SURGICAL SITE INFECTION AFTER INITIAL IMPLANTATION WITH AN IMPLANT. THERE WAS NO ACTUAL DEVICE MALFUNCTION REPORTED OR EVIDENCE OF SUCH, AND THE PROCEDURE WAS REPORTED AS COMPLETED SUCCESSFULLY.
Patient problems: Post Operative Wound Infection
MAUDE report 8712858 ↗
Other Plate, cranioplasty, preformed, alterable devices
- OsteoMed 218-1604Osteomed LLC · Plate, cranioplasty, preformed, alterable1 recall6 reports
- 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
- 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.