MatrixNEURO 04.503.062Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887587017945), received between Mar 2, 2018 and Oct 12, 2021 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT DEVELOPED AN INFECTION, AND A NEW PATIENT SPECIFIC IMPLANT (PSI) HAS BEEN REQUESTED. THE PATIENT HAD IMPLANTS ON (B)(6) 2021. THE IMPLANT WAS REMOVED (B)(6) 2021, DUE TO INFECTION. IT WAS UNKNOWN IF THE REMOVAL SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS FINE. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) TI MATRIXNEURO STRAIGHT PLATE 2 HOLES/12. THIS REPORT IS 14 OF 15 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 12619556 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT DEVELOPED AN INFECTION, AND A NEW PATIENT SPECIFIC IMPLANT (PSI) HAS BEEN REQUESTED. THE PATIENT HAD IMPLANTS ON (B)(6) 2021. THE IMPLANT WAS REMOVED (B)(6) 2021, DUE TO INFECTION. IT WAS UNKNOWN IF THE REMOVAL SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS FINE. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) TI MATRIXNEURO STRAIGHT PLATE 2 HOLES/12MM. THIS REPORT IS 12 OF 15 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 12619554 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT DEVELOPED AN INFECTION, AND A NEW PATIENT SPECIFIC IMPLANT (PSI) HAS BEEN REQUESTED. THE PATIENT HAD IMPLANTS ON (B)(6) 2021. THE IMPLANT WAS REMOVED (B)(6) 2021, DUE TO INFECTION. IT WAS UNKNOWN IF THE REMOVAL SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS FINE. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES. THIS REPORT IS FOR (1) TI MATRIXNEURO STRAIGHT PLATE 2 HOLES/12MM. THIS REPORT IS 2 OF 15 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 12619182 ↗
• InjuryMar 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A PATIENT SPECIFIC IMPLANT, MATRIXNEURO PLATES AND MATRIXNEURO SCREWS ON (B)(6) 2018 FOR A CRANIOPLASTY. PATIENT DEVELOPED INFECTION AND THE IMPLANTS WERE REMOVED ON AN UNKNOWN DATE. PATIENT WILL BE IMPLANTED WITH ANOTHER PATIENT SPECIFIC IMPLANT. THE SURGERY DATE HAS NOT BEEN SCHEDULED. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES (PATIENT SPECIFIC IMPLANT, MATRIXNEURO PLATES AND MATRIXNEURO SCREWS). THIS REPORT IS FOR 10 DEVICES. THIS REPORT IS 8 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7310918 ↗
• InjuryMar 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A PATIENT SPECIFIC IMPLANT, MATRIXNEURO PLATES AND MATRIXNEURO SCREWS ON (B)(6) 2018 FOR A CRANIOPLASTY. PATIENT DEVELOPED INFECTION AND THE IMPLANTS WERE REMOVED ON AN UNKNOWN DATE. PATIENT WILL BE IMPLANTED WITH ANOTHER PATIENT SPECIFIC IMPLANT. THE SURGERY DATE HAS NOT BEEN SCHEDULED. THIS COMPLAINT INVOLVES AN UNKNOWN NUMBER OF DEVICES (PATIENT SPECIFIC IMPLANT, , MATRIXNEURO PLATES AND MATRIXNEURO SCREWS). THIS REPORT IS FOR 10 DEVICES. THIS REPORT IS 7 OF 10 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7310802 ↗

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