MatrixNEURO 04.503.098Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587018287), received between Feb 23, 2026 and Feb 23, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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.

• MalfunctionFeb 23, 2026Material Deformation

  IT WAS REPORTED THAT A LARGE MASTOID MESH PLATE WAS DAMAGED, WHERE ONE OF THE SCREW HOLES WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415795 ↗

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