MatrixNEURO 04.503.121Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587018485), received between Dec 8, 2017 and Jan 14, 2020 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REMOVAL OF CRANIOS REINFORCED FAST SET PUTTY, ONE (1)TITANIUM MATRIXNEURO RECONSTRUCTION MESH, ONE (1) 3MM TITANIUM MATRIX MIDFACE SCREW, ONE (1) 10MM TITANIUM MATRIX MIDFACE SCREW, AND ONE (1) 4MM TITANIUM MATRIX MIDFACE SCREW DUE TO C DIFFICILE INFECTION POSTOPERATIVELY. ORIGINAL DATE OF SURGERY WAS ON (B)(6) 2015. THE PATIENT WAS ON A CEPHALEXIN ANTIBIOTIC THERAPY DUE TO COMPLICATION KNOWN ON (B)(6) 2015. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) TI MATRIXNEURO CONTOUR MESH 100MM X 100MM/0.6MM RIGID. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9587449 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT HAD A CRANIOTOMY. PATIENT WAS IMPLANTED WITH A TITANIUM (TI) MATRIXNEURO CONTOUR MESH, UNKNOWN QUANTITY OF TI MATRIXNEURO SCREWS, AND NON-SYNTHES DEVICE NOTED AS A SUTURABLE DURAGEN. POSTOPERATIVELY, ON AN UNKNOWN DATE, THE PATIENT DEVELOPED A REACTION TO THE IMPLANTS, WHICH THE HOSPITAL NURSE STATED WAS HIVES. THE PATIENT REMAINED IN STABLE CONDITION. THERE WAS NO REPORTED DAMAGE TO ANY OF THESE DEVICES. CONCOMITANT DEVICE REPORTED: NON-SYNTHES SUTURABLE DURAGEN DEVICE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TI MATRIXNEURO CONTOUR MESH 100MMX100MM/0.6MM RIGID. THIS IS REPORT 1 OF 2 FOR PC-000067311.

  Patient problems: Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7109474 ↗
• InjuryDec 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A REACTION TO IMPLANTED HARDWARE. THE PATIENT WAS IMPLANTED WITH SYNTHES ROSE THICK MESH AND SYNTHES 4MM SELF DRILLING SCREWS ON AN UNKNOWN DATE APPROXIMATELY FEW MONTHS PRIOR TO REPORTING. THIS REPORT IS FOR ONE (1) TI MATRIXNEURO CONTOUR MESH. THIS IS REPORT 1 OF 2 FOR (B)(6).

  Patient problems: Reaction

  MAUDE report 7101163 ↗

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