MatrixNEURO 04.502.022Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587017525), 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 18, 2026.

Most reported problems

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 A 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 (B)(6) 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 23619652 ↗

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 · Terminated
  MatrixNEURO 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