Plate, Cranioplasty, Preformed, Alterable
FDA adverse event reports and recall history for plate, cranioplasty, preformed, alterable (product code GWO), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 927
- Deaths
- 0
- Injuries
- 197
- Malfunctions
- 725
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-05-08Open, ClassifiedUnder Investigation by firm
Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614
Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
- 2023-07-07Open, ClassifiedNonconforming Material/Component
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
- 2023-07-07Open, ClassifiedNonconforming Material/Component
REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
- 2008-04-24TerminatedEnvironmental control
ECG Lead Set 60 in SOC to Snap model number 8049-1. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Foreign material: Glass fragments may present in the plastic bag material used to ship components.
- TerminatedComponent change control
Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
- TerminatedComponent change control
Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
- TerminatedPackage design/selection
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- TerminatedPackage design/selection
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- TerminatedPackage design/selection
QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- TerminatedPackage design/selection
QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Monitor plate, cranioplasty, preformed, alterable automatically
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