MatrixNEURO 04.503.069Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587018010), received between Mar 6, 2020 and Mar 6, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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

• InjuryMar 6, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL OF THE TWO (2) BROKEN TITANIUM MATRIXN EURO DOUBLE Y-PLATE SIX HOLES ATTACHED TO PATIENT SPECIFIC IMPLANTS (PSI). THE CAUSE OF THE BREAKAGE WAS UNKNOWN AND WHEN THE IMPLANTED PLATES WERE BROKEN. THE PATIENT HAD POST INITIAL SURGERY SIX (6) MONTHS AGO. ALL HARDWARE WERE REMOVED AND REPLACED WITHOUT ISSUE. THERE WAS NO INJURY TO PATIENT. NO FRAGMENTS REMAINED PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN) THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 9800199 ↗
• InjuryMar 6, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL OF THE TWO (2) BROKEN TITANIUM MATRIXNEURO DOUBLE Y-PLATE SIX HOLES ATTACHED TO PATIENT SPECIFIC IMPLANTS (PSI). THE CAUSE OF THE BREAKAGE WAS UNKNOWN AND WHEN THE IMPLANTED PLATES WERE BROKEN. THE PATIENT HAD POST INITIAL SURGERY SIX (6) MONTHS AGO. ALL HARDWARE WERE REMOVED AND REPLACED WITHOUT ISSUE. THERE WAS NO INJURY TO PATIENT. NO FRAGMENTS REMAINED PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 9800027 ↗

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