NA 78-70040Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · PEEK CUSTOMIZED-PLUS-XL · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327300031), received between Feb 17, 2021 and Sep 14, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 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 Size2
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Inadequacy of Device Shape and/or Size
It was reported that the implant demonstrated an acceptable fit posteriorly, while a gap was present anteriorly between the implant and the native bone. No surgical delay or any medical intervention were reported at intake.
Patient problems: Insufficient Information
MAUDE report 50750887 ↗MalfunctionFeb 17, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT THE SURGEON ENCOUNTERED DIFFICULTIES WITH SETTING THE PLATE AND NOTICED THE IMPLANT WAS CURVED UPWARDS. IN ORDER FOR THE PLATE TO FIT CORRECTLY, THE SURGEON HAD TO CUT PART OF THE PLATE OFF. THERE IS NO OTHER INFORMATION KNOWN AT THIS TIME.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11337127 ↗
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.