MatrixNEURO 04.503.083Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587018126), received between Jan 14, 2020 and Jan 14, 2020 — classified as 1 injury.

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.

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

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO CHRONIC INFECTION. ORIGINALLY, THE PATIENT HAD AN IMPLANTATION USING A TITANIUM MESH AND SCREWS DUE TO CRANIAL VAULT RESHAPING IN INFANCY IN (B)(6) 2016. HOWEVER, COMPLICATION WAS OBSERVED DUE TO INFECTION THAT WAS KNOWN IN (B)(6) 2016 AND THAT PATIENT WAS ON ANTIBIOTIC THERAPY OF CEPHALEXIN. THUS, A RE-OPERATION WAS DONE IN (B)(6) 2016. UNFORTUNATELY, A RE-OPERATIVE FINDING SHOWN THAT THE CRANIOPLASTY MATERIAL IN SOME AREAS LOOKED QUITE SATISFACTORY BUT IN OTHER AREAS WAS OBVIOUSLY INFECTED. IT WAS ALSO MENTIONED THAT THIS WOULD NEED TO BE REMOVED, AND THE SURGEON AWARE THAT THERE WAS A SUBJACENT FRONTAL BONE TITANIUM MESH CRANIOPLASTY ON THE LEFT THAT WOULD NEED TO BE REMOVED AND REPLACED. SO, WOUND CULTURE WAS DONE WITH NORMAL SKIN FLORA, NO FUNGUS WAS NOTED AND WOUND CULTURE IN OFFICE GREW PSEUDOMONAS AND WAS ON BACTRIM AND CIPRO PRE-OP. THUS, ANOTHER SURGERY WAS DONE ON (B)(6) 2019 WHEREIN BONE AND SOFT TISSUES WERE DEBRIDED, AND BONE AND HARDWARE WERE REMOVED IN THE LEFT FRONTAL BONE. THE PATIENT HAS A SHEET OF TITANIUM MESH OVER THE CRANIAL DEFECT IN THE LEFT FRONT

  Patient problems: Impaired Healing; No Code Available; Unspecified Infection

  MAUDE report 9587097 ↗

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