MatrixNEURO 04.503.061Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10887587017938), received between Jul 10, 2018 and Jul 10, 2018 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH POLYETHERETHERKETONE (PEEK) PATIENT-SPECIFIC IMPLANTS (PSI) AS A BIFRONTAL CRANIOPLASTY ON AN UNKNOWN DATE. AFTER APPROXIMATELY ONE MONTH, IMPLANTS HAD TO BE REMOVED DUE TO INFECTION. THE HARDWARE REMOVAL WAS SUCCESSFULLY COMPLETED. REVISION SURGERY WILL BE SCHEDULED TO INSERT A NEW FLAP ONCE PATIENT HEALS FROM INFECTION. PATIENT OUTCOME WAS SATISFACTORY. THIS IS REPORT 8 OF 9 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7674381 ↗
• InjuryJul 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH POLYETHERETHERKETONE (PEEK) PATIENT-SPECIFIC IMPLANTS (PSI) AS A BIFRONTAL CRANIOPLASTY ON AN UNKNOWN DATE. AFTER APPROXIMATELY ONE MONTH, IMPLANTS HAD TO BE REMOVED DUE TO INFECTION. THE HARDWARE REMOVAL WAS SUCCESSFULLY COMPLETED. REVISION SURGERY WILL BE SCHEDULED TO INSERT A NEW FLAP ONCE PATIENT HEALS FROM INFECTION. PATIENT OUTCOME WAS SATISFACTORY. THIS IS REPORT 7 OF 9 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7674151 ↗
• InjuryJul 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH POLYETHERETHERKETONE (PEEK) PATIENT-SPECIFIC IMPLANTS (PSI) AS A BIFRONTAL CRANIOPLASTY ON AN UNKNOWN DATE. AFTER APPROXIMATELY ONE MONTH, IMPLANTS HAD TO BE REMOVED DUE TO INFECTION. THE HARDWARE REMOVAL WAS SUCCESSFULLY COMPLETED. REVISION SURGERY WILL BE SCHEDULED TO INSERT A NEW FLAP ONCE PATIENT HEALS FROM INFECTION. PATIENT OUTCOME WAS SATISFACTORY. THIS IS REPORT 6 OF 9 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7674114 ↗
• InjuryJul 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH POLYETHERETHERKETONE (PEEK) PATIENT-SPECIFIC IMPLANTS (PSI) AS A BIFRONTAL CRANIOPLASTY ON AN UNKNOWN DATE. AFTER APPROXIMATELY ONE MONTH, IMPLANTS HAD TO BE REMOVED DUE TO INFECTION. THE HARDWARE REMOVAL WAS SUCCESSFULLY COMPLETED. REVISION SURGERY WILL BE SCHEDULED TO INSERT A NEW FLAP ONCE PATIENT HEALS FROM INFECTION. PATIENT OUTCOME WAS SATISFACTORY. THIS IS REPORT 5 OF 9 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7674053 ↗
• InjuryJul 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH POLYETHERETHERKETONE (PEEK) PATIENT-SPECIFIC IMPLANTS (PSI) AS A BIFRONTAL CRANIOPLASTY ON AN UNKNOWN DATE. AFTER APPROXIMATELY ONE MONTH, IMPLANTS HAD TO BE REMOVED DUE TO INFECTION. THE HARDWARE REMOVAL WAS SUCCESSFULLY COMPLETED. REVISION SURGERY WILL BE SCHEDULED TO INSERT A NEW FLAP ONCE PATIENT HEALS FROM INFECTION. PATIENT OUTCOME WAS SATISFACTORY. THIS IS REPORT 4 OF 9 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7674006 ↗
• InjuryJul 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH POLYETHERETHERKETONE (PEEK) PATIENT-SPECIFIC IMPLANTS (PSI) AS A BIFRONTAL CRANIOPLASTY ON AN UNKNOWN DATE. AFTER APPROXIMATELY ONE MONTH, IMPLANTS HAD TO BE REMOVED DUE TO INFECTION. THE HARDWARE REMOVAL WAS SUCCESSFULLY COMPLETED. REVISION SURGERY WILL BE SCHEDULED TO INSERT A NEW FLAP ONCE PATIENT HEALS FROM INFECTION. PATIENT OUTCOME WAS SATISFACTORY. THIS IS REPORT 3 OF 9 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7673940 ↗
• InjuryJul 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH POLYETHERETHERKETONE (PEEK) PATIENT-SPECIFIC IMPLANTS (PSI) AS A BIFRONTAL CRANIOPLASTY ON AN UNKNOWN DATE. AFTER APPROXIMATELY ONE MONTH, IMPLANTS HAD TO BE REMOVED DUE TO INFECTION. THE HARDWARE REMOVAL WAS SUCCESSFULLY COMPLETED. REVISION SURGERY WILL BE SCHEDULED TO INSERT A NEW FLAP ONCE PATIENT HEALS FROM INFECTION. PATIENT OUTCOME WAS SATISFACTORY. THIS IS REPORT 2 OF 9 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7673885 ↗

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