NA 78-50020Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · PEEK Customized Cranial Implant Prio, M · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327129281), received between Jun 8, 2021 and May 28, 2026 — classified as 4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size3
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2026Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT DURING A CRANIOPLASTY PROCEDURE, A SIGNIFICANT IMPLANT FIT CONCERN WAS IDENTIFIED INVOLVING THE PEEK IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25315226 ↗MalfunctionJan 21, 2026Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT WITHIN THE PEEK STUDY 2023, THE IMPLANT REQUIRED SLIGHT ADJUSTMENT DUE TO A CHANGE OF ANATOMY/CALCIFICATIONS. THIS CAUSED A DELAY OF 10 MINUTES. THE PATIENT WAS INVOLVED, BUT NO PATIENT IMPACT OR ADVERSE CONSEQUENCES WERE REPORTED AT INTAKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24131040 ↗MalfunctionNov 13, 2023Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE IMPLANT WAS MANUFACTURED AND DID NOT MEET THE THICKNESS SPECIFICATIONS. THERE WERE NO REPORTED ADVERSE EVENTS HOWEVER, THIS PRODUCT FAILURE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT SHOULD IT HAPPEN AGAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18121963 ↗MalfunctionJun 8, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON STATED THEY WERE UNHAPPY WITH THE FIT AND CONTOUR OF THE IMPLANT. NO OTHER INFORMATION IS KNOWN AT THIS TIME.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11957348 ↗
Other Plate, cranioplasty, preformed, alterable devices
- OsteoMed 218-1604Osteomed LLC · Plate, cranioplasty, preformed, alterable1 recall6 reports
- OsteoMed 218-1604-SP-10Osteomed LLC · Plate, cranioplasty, preformed, alterable1 recall0 reports
- NA 56-90614Stryker Leibinger GmbH & Co. KG · 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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