MatrixNEURO 04.503.097Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587018270), received between Apr 9, 2026 and Apr 21, 2026 — classified as 2 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Nonstandard Device

  IT WAS REPORTED THAT THE ONE OF THE SCREW HOLES OF THE TI MATRIXNEURO CONTOUR MESH MASTOID/MEDIUM/MALLEABLE IS SIDEWAYS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24944881 ↗
• MalfunctionApr 9, 2026Material Deformation

  ADDITIONAL INFORMATION RECEIVED: A. WHEN DID THE EVENT OCCURRED? (PRE-OP, INTRA-OP, POST-OP) - PRE-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830817 ↗

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