NA 78-60030Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · PEEK CUSTOMIZED COMPLEX-PLUS-L · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327300062), received between Mar 26, 2020 and Jun 18, 2025 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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 Size3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Deformity/ Disfigurement1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 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 22282774 ↗MalfunctionNov 6, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE PEEK CCI IMPLANT DID NOT FIT AS EXPECTED; IT WAS LARGER THAN THE ACTUAL DEFECT. PORTIONS OF THE IMPLANT WERE CUT INTRA-OPERATIVELY IN ORDER TO IMPLANT THE DEVICE SUCCESSFULLY. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10802028 ↗MalfunctionOct 20, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT DURING A CASE, THE PEEK CUSTOMIZED IMPLANT DID NOT FIT AS INTENDED. THE IMPLANT WAS DESIGNED AS A PTERIONAL PLUS; HOWEVER, THE SURGEON NEEDED TO BURR DOWN THE INTERIOR OF THE IMPLANT, AND THE PATIENT WAS STILL LEFT WITH SOME TEMPORAL HOLLOWING.
Patient problems: Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions
MAUDE report 10706667 ↗InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT THE PRODUCT WAS IMPLANTED AND BLEEDING WAS NOTICED UNDER THE IMPLANT POST OPERATIVELY. THERE WAS A REVISION SURGERY COMPLETED TO REMOVE THE IMPLANT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 9883632 ↗
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
- 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.