NA 78-40030Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · PEEK Customized Cranial Implant, L · Class 2 · Implant
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327129298), received between Sep 5, 2018 and Jan 15, 2026 — classified as 3 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (7 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 Size7
- Fitting Problem2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information2
- Bacterial Infection1
- Cerebral Edema1
- No Known Impact Or Consequence To Patient1
- Wound Dehiscence1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2026Inadequacy of Device Shape and/or Size
IMPLANT DID NOT FIT THE PATIENT IN SURGERY. SURGEON USED TITANIUM MESH AS ALTERNATIVE TO THE PEEK IMPLANT. FITTING ISSUE CAUSED AN SURGICAL DELAY OF 16-60 MIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24077874 ↗MalfunctionApr 24, 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 21900419 ↗MalfunctionApr 24, 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 CEREBRAL SWELLING, SOFT TISSUE INTERFERENCE AND CHANGES OF ANATOMY/CALCIFICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21900208 ↗MalfunctionJan 21, 2025Inadequacy of Device Shape and/or Size; Fitting Problem; Inadequacy of Device Shape and/or Size; Fitting Problem
IT WAS REPORTED THAT THE IMPLANT DID NOT FIT AS PLANNED, AND IT WAS MODIFIED DURING SURGERY; NEVERTHELESS, POST-OP THERE WAS AN AESTHETIC DEFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21196956 ↗MalfunctionDec 17, 2024Fitting Problem; Fitting Problem
IT WAS REPORTED THAT THE IMPLANT DID NOT FIT WELL.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20955034 ↗InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THERE WAS A REVISION SURGERY PERFORMED TO REVISE THE IMPLANT DUE TO PATIENT PRESENTING WITH A WOUND DEHISCENCE.
Patient problems: Bacterial Infection; Wound Dehiscence
MAUDE report 19082144 ↗InjuryMar 20, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THE SHAPE OF THE IMPLANT DID NOT FIT AS EXPECTED AND COULD NOT BE USED TO COMPLETE THE SURGERY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18943923 ↗InjuryMar 31, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT DURING THE SURGERY, IT WAS NOTICED THE PEEK IMPLANT WAS TOO SMALL AND NOT CURVED AS EXPECTED. AN ALTERNATIVE IMPLANT WAS USED. A REVISION SURGERY WAS SUCCESSFULLY PERFORMED TO IMPLANT A NEW PEEK IMPLANT.
Patient problems: Cerebral Edema; No Clinical Signs, Symptoms or Conditions
MAUDE report 13971162 ↗MalfunctionSep 5, 2018Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THERE WAS A DISCREPANCY BETWEEN THE IMPLANT AND THE CRANIAL SHAPE, THIS IMPLANT WAS NOT USED. AN ALTERNATIVE IMPLANT WAS USED. THE SURGERY WAS DELAYED FOR AN HOUR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7846170 ↗
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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.