MatrixNEURO 04.503.065Recalls & reported problems
Synthes GmbH · TI MATRIXNEURO BOX PLATE 14MM X 14MM · Class 2 · Implant
All models of MatrixNEURO (25)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587017976), received between Nov 21, 2025 and Nov 21, 2025 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K042365, K123723); they may or may not involve this specific model.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL CRANIAL FIXATION WITH SYNTHES CMF HARDWARE IN 2002, FOLLOWED BY ADDITIONAL PROCEDURES IN 2006 AND 2011. OVER TIME PATIENT DEVELOPED HARDWARE EXPOSURE OF CRANIAL TITANIUM MESH/PLATES AND EVENTUALLY FOUND A LOOSE SCREW ON THE PILLOW (DEC 2022). CLINICAL NOTES DOCUMENTED EXPOSED SCREW AND COLONIZED EXPOSED MESH/HARDWARE. IN 2023, SURGEON PERFORMED REMOVAL OF EXPOSED TITANIUM MESH AND HARDWARE, WITH ROTATIONAL-ADVANCEMENT SCALP FLAPS. PATIENT HAS UNDERGONE MULTIPLE REVISION SURGERIES OVER THE YEARS FOR HARDWARE EXPOSURE AND WOUND COMPLICATIONS. RELATED COMPLAINTS (B)(4) CAPTURE PATIENT'S ADDITIONAL SURGERIES.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 23619643 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K042365, K123723. One submission often covers many models, so check the product and lot details in each record.
- Z-2698-2020 · Jun 18, 2020 · TerminatedMatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedur
Other PLATE, BONE devices
- MatrixNEURO 04.503.104.01Synthes GmbH · PLATE, BONE252 reports
- RapidSorb 806.004.02SSynthes GmbH · PLATE, BONE146 reports
- TruMatch SD980.001Materialise NV · Plate, Bone1 recall21 reports
- Matrix 04.511.225.01Synthes GmbH · PLATE, BONE62 reports
- NA 400.834Synthes GmbH · PLATE, BONE58 reports
- TruMatch SD980.016Materialise NV · Plate, Bone55 reports
- ProPlan CMF SD900.101Materialise NV · Plate, Bone1 recall1 report
- TruMatch SD980.013Materialise NV · Plate, Bone1 recall0 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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