MatrixNEURO 04.503.057Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587017921), received between Oct 22, 2025 and Oct 22, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025, DURING A CRANIOTOMY CASE, THE PLATE HOLE ON THE TI MATRIXNEURO TEMPORAL MSH MED/MALLE BROKE WHEN SURGEON WAS INSERTING THE SCREW WITH THE MATRIX PRODRIVER. THERE WAS A SURGICAL DELAY AS IMPLANT HAD TO BE REMOVED AND A NEW ONE IMPLANTED. THE SURGERY WAS SUCCESSFUL AND PATIENT OUTCOME IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23361524 ↗

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