Plate, Cranioplasty, Preformed, Alterable
Neurology · 21 CFR 882.5320
Recent MDR events
944 adverse event reports on file
- TI MATRIXNEURO SCREW SELF-DRILLING 4MMJul 31, 2026MalfunctionSynthes Gmbh8030965-2026-07875
- TI MATRIXNEURO SCREW SELF-DRILLING 4MMJul 31, 2026MalfunctionSynthes Gmbh8030965-2026-07876
- TI MATRIXNEURO SCREW SELF-DRILLING 4MMJul 31, 2026MalfunctionSynthes Gmbh8030965-2026-07877
- TI MATRIXNEURO SCREW SELF-DRILLING 4MMJul 31, 2026MalfunctionSynthes Gmbh8030965-2026-07878
- TI MATRIXNEURO SCREW SELF-DRILLING 4MMJul 27, 2026MalfunctionSynthes Gmbh8030965-2026-07522
- TI MATRIXNEURO SCREW SELF-DRILLING 4MMJul 27, 2026MalfunctionSynthes Gmbh8030965-2026-07687
- PEEK CUSTOMIZED-PLUS-MJul 27, 2026MalfunctionStryker Leibinger Freiburg0008010177-2026-00120
- TI MATRIXNEURO SCREW SELF-DRILLING 5MMJul 27, 2026MalfunctionSynthes Gmbh8030965-2026-07698
- TI MATRIXNEURO SCREW SELF-DRILLING 5MMJul 27, 2026MalfunctionSynthes Gmbh8030965-2026-07707
- TI MATRIXNEURO SCREW SELF-DRILLING 4MMJul 27, 2026MalfunctionSynthes Gmbh8030965-2026-07744
Event type breakdown
Recalls
24 recall events for this product code
- Stryker Leibinger GmbH & Co. KGOpen, ClassifiedMay 8, 2024
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.
Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
Z-1785-2024 · View FDA record ↗ - Osteomed, LLCOpen, ClassifiedJul 7, 2023
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.
Z-2107-2023 · View FDA record ↗ - Osteomed, LLCOpen, ClassifiedJul 7, 2023
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.
Z-2108-2023 · View FDA record ↗ - Respironics, Inc.TerminatedApr 24, 2008
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
Foreign material: Glass fragments may present in the plastic bag material used to ship components.
Z-1090-2008 · View FDA record ↗ - Biomet Microfixation, LLCTerminatedUnknown
Neuro Combo Set Case
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.
Z-0136-2016 · View FDA record ↗ - Biomet Microfixation, LLCTerminatedUnknown
Thinflap System Case
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.
Z-0137-2016 · View FDA record ↗ - Stryker Leibinger GmbH & Co. KGTerminatedUnknown
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Z-2898-2018 · View FDA record ↗ - Stryker Leibinger GmbH & Co. KGTerminatedUnknown
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S
After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
Z-2899-2018 · View FDA record ↗ - Stryker Leibinger GmbH & Co. KGTerminatedUnknown
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.
Z-2900-2018 · View FDA record ↗ - Stryker Leibinger GmbH & Co. KGTerminatedUnknown
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.
Z-2901-2018 · View FDA record ↗
Registered firms
71 firms currently registered for this product code
Jabil Inc. (monument)
Monument, CO, US
Jeil Medical Corporation
Seoul, KR
Stryker Leibinger Gmbh & Co. Kg
FREIBURG Baden-Wurttemberg, DE
Synthes (usa) Products Llc
West Chester, PA, US
Depuy Orthopaedics
BRIDGEWATER, MA, US
Kls-martin L.p.
Jacksonville, FL, US
Aesculap, Inc.
CENTER VALLEY, PA, US
Sterigenics U.s. Llc
MULBERRY, FL, US
Osteonic Co., Ltd.
Seoul, KR
Depuy Synthes Sales
Bridgewater, MA, US
Osteomed
ADDISON, TX, US
Kelyniam Global Inc.
COLLINSVILLE, CT, US
Kinamed, Inc.
CAMARILLO, CA, US
Jabil Inc. (brandywine)
W Chester, PA, US
3d Medical Applications Center (3d Mac)
Bethesda, MD, US
Dsm Biomedical, Inc.
EXTON, PA, US
Microware Precision Co., Ltd.
Taichung, TW
510(k) clearances
43 clearances for this product code
- CraniUS, LLCJul 29, 2026
K261058 · CraniUS Plate
- Techfit Digital Surgery, Inc.Oct 27, 2025
K250297 · TECHFIT Patient-Specific Cranial System
- Kelyniam Global, Inc.Jul 25, 2025
K250334 · Fusion Craniofacial Implant; Fusion Skull Implant
- 3D Systems, Inc.Apr 4, 2024
K231834 · VSP PEEK Cranial Implant
- Mci Medical Concept Innovation, Inc.Oct 21, 2022
K212391 · MCI-Neuro Fixation System
- Osteonic Co., Ltd.Jan 27, 2022
K210360 · Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
- StrykerFeb 9, 2021
K203055 · Stryker PEEK Customized Cranial Implant Kit
- Osteonic Co., Ltd.Nov 27, 2019
K190811 · Optimus NEURO System - Sterile Kit