MatrixNEURO 04.503.073Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587018058), received between Sep 5, 2018 and Sep 5, 2018 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH ONE (1) PATIENT SPECIFIC IMPLANT (PSI) POLYETHERETHERKETONE (PEEK) IMPLANT, FIFTEEN (15) MATRIXNEURO SCREWS, AND FOUR (4) MATRIXNEURO BOX PLATES ON UNKNOWN DATE. ON UNKNOWN DATE IT WAS DETERMINED PATIENT HAD DEVELOPED AN INFECTION AT THE IMPLANT SITE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. IT IS NOT KNOWN IF ADDITIONAL HARDWARE WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. DUE TO SYSTEM LIMITATIONS, THE PSI PEEK IMPLANT AND NINE (9) OF THE SCREWS ARE ADDRESSED IN (B)(4). THIS REPORT WILL ADDRESS THE REMAINING DEVICES. THIS REPORT IS FOR ONE (1) MATRIXNEURO BOX PLATE. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7847307 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH ONE (1) PATIENT SPECIFIC IMPLANT (PSI) POLYETHERETHERKETONE (PEEK) IMPLANT, FIFTEEN (15) MATRIXNEURO SCREWS, AND FOUR (4) MATRIXNEURO BOX PLATES ON UNKNOWN DATE. ON UNKNOWN DATE IT WAS DETERMINED PATIENT HAD DEVELOPED AN INFECTION AT THE IMPLANT SITE. PATIENT WAS RETURNED TO SURGERY ON AUGUST 4, 2018 WHERE ALL HARDWARE WAS REMOVED. IT IS NOT KNOWN IF ADDITIONAL HARDWARE WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. DUE TO SYSTEM LIMITATIONS, THE PSI PEEK IMPLANT AND NINE (9) OF THE SCREWS ARE ADDRESSED IN (B)(4). THIS REPORT WILL ADDRESS THE REMAINING DEVICES. THIS REPORT IS FOR ONE (1) MATRIXNEURO BOX PLATE. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7847276 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH ONE (1) PATIENT SPECIFIC IMPLANT (PSI) POLYETHERETHERKETONE (PEEK) IMPLANT, FIFTEEN (15) MATRIXNEURO SCREWS, AND FOUR (4) MATRIXNEURO BOX PLATES ON UNKNOWN DATE. ON UNKNOWN DATE IT WAS DETERMINED PATIENT HAD DEVELOPED AN INFECTION AT THE IMPLANT SITE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. IT IS NOT KNOWN IF ADDITIONAL HARDWARE WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. DUE TO SYSTEM LIMITATIONS, THE PSI PEEK IMPLANT AND NINE (9) OF THE SCREWS ARE ADDRESSED IN (B)(4). THIS REPORT WILL ADDRESS THE REMAINING DEVICES. THIS REPORT IS FOR ONE (1) MATRIXNEURO BOX PLATE THIS IS REPORT 8 OF 10 FOR (B)(4)

  Patient problems: Unspecified Infection

  MAUDE report 7847233 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH ONE (1) PATIENT SPECIFIC IMPLANT (PSI) POLYETHERETHERKETONE (PEEK) IMPLANT, FIFTEEN (15) MATRIXNEURO SCREWS, AND FOUR (4) MATRIXNEURO BOX PLATES ON UNKNOWN DATE. ON UNKNOWN DATE IT WAS DETERMINED PATIENT HAD DEVELOPED AN INFECTION AT THE IMPLANT SITE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. IT IS NOT KNOWN IF ADDITIONAL HARDWARE WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. DUE TO SYSTEM LIMITATIONS, THE PSI PEEK IMPLANT AND NINE (9) OF THE SCREWS ARE ADDRESSED IN (B)(4). THIS REPORT WILL ADDRESS THE REMAINING DEVICES. THIS REPORT IS FOR ONE (1) MATRIXNEURO BOX PLATE. THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7846916 ↗

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