MatrixNEURO 04.503.122Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587018492), received between Aug 18, 2021 and Dec 12, 2023 — 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.

• InjuryDec 12, 2023Break; Break

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT IN QUESTION HAD A CRANIOPLASTY PROCEDURE ON (B)(6) 2018. DURING A RECENT EXAMINATION IN NOVEMBER OF 2023, IT WAS DISCOVERED THAT THE TITANIUM MESH USED DURING THE SURGERY HAD BEEN FRACTURED. THIS RESULTED IN DAMAGE TO THE SCALP AND EXPOSURE OF THE IMPLANT. AS A RESULT, A REVISION PROCEDURE WAS DEEMED NECESSARY BUT HAS NOT BEEN SCHEDULED YET. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI MATRIX NEURO CONTOUR MESH 200MM X 200MM/0.6MM RIGID. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Confusion/ Disorientation; Unspecified Tissue Injury

  MAUDE report 18310442 ↗
• InjuryAug 18, 2021Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT IN (B)(6) OR (B)(6) 2018 MESH COLLAPSE BEGAN. THE MESH WAS ORIGINALLY IMPLANTED ON (B)(6) 2016 DUE TO A DEFECT OF THE SKULL. IN 2021, THE PATIENT REPORTED THE ISSUE TO THE HOSPITAL. A CT WAS PERFORMED WHICH CONFIRMED THE MESH WAS COLLAPSED. THE PATIENT IS STABLE SO FAR. NO OTHER INFORMATION PROVIDED. FURTHER INFORMATION COULD BE ADDED IF PROVIDED. THIS REPORT IS FOR MESH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 12339067 ↗

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