MatrixNEURO 04.503.029Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587017853), received between Jan 9, 2025 and Jan 9, 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 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.

• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, ONE OF SURGEONS HAD AN ADVERSE EVENT OCCUR WHILE DOING A CRANIOPLASTY. THE SURGEON WAS USING OUR PRODRIVER TO DRIVE A SCREW INTO PLATE SHUNT COVER AND THE FIXATION HOLE SPLIT. A SURGICAL DELAY OCCURRED BECAUSE THE SURGEON HAD TO TAKE THE BROKEN IMPLANT OFF AND PUT A NEW ONE ON. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS OKAY.

  Patient problems: Insufficient Information

  MAUDE report 21112744 ↗

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