MatrixNEURO 04.502.073Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587017716), received between Jun 18, 2019 and Jun 18, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• MalfunctionJun 18, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE TITANIUM ULTRA LOW PROFILE (ULP) MATRIXNEURO BOX PLATE WAS MANIPULATED DURING IMPLANTATION AND WHEN THE SCREW WAS INSERTED, THE SCREW WENT THROUGH THE PLATE SCREW HOLE ENTIRELY. THE DIAMETER OF THE PLATE WAS EXTENDED TO THE POINT THAT THE SCREW HEAD NO LONGER HELD THE PLATE DOWN PROPERLY. THE SURGEON SUGGESTED THAT THE PLATE ENGINEERING CONSTRUCT WAS POTENTIALLY FAULTY. HE DID NOT THINK HE BENT THE PLATE ENOUGH TO ALTER THE SHAPE OF THE SCREW HOLE AND THAT THE DIAMETER OF THE HOLE WAS LARGER THAN STATED, ALLOWING THE SCREW TO GO THROUGH ENTIRELY. THERE WERE NO FRAGMENTS GENERATED AND NO SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES: MATRIXNEURO SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN) THIS REPORT IS FOR A TITANIUM (TI) MATRIXNEURO ULP 10MM X 16MM BOX PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707124 ↗

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