MatrixNEURO 04.503.072Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587018041), received between Aug 14, 2020 and Aug 19, 2020 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN ACOUSTIC NEUROMA RESECTION RETROSIGMOID PROCEDURE. THE PATIENT WAS IMPLANTED WITH TITANIUM MATRIXNEURO ADAPTATION PLATE AND CRANIOS REINFORCED FAST SET PUTTY. THERE WAS A SURGICAL TIME OF 568 MINUTES. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. POSTOPERATIVELY, ON AN UNKNOWN DATE, PATIENT WAS ADMITTED TO HOSPITAL FOR WOUND DRAINAGE, STOPPED WITH GLUE. IT WAS UNCLEAR WHETHER POSTOPERATIVE COMPLICATION(S) WAS (WERE) DUE TO DEVICE. THE INFECTED BONE PLATE TREATED WITH SURGERY TO REMOVE ALL HARDWARE. THE HEALING STATUS/RADIOGRAPHIC OUTCOMES AT FINAL FOLLOW-UP WAS THE LARGE SYMPTOMATIC LEFT ACOUSTIC NEUROMA DOING GREAT AFTER NEAR TOTAL RESECTION OF SCHWANNOMA. INFECTION HAS BEEN TREATED, AND HIS WOUND LOOKS GOOD. HE HAS NO BONE FLAP BECAUSE IT WAS REMOVED FOR INFECTION. OTHER OUTCOME ASSESSMENTS OR PATIENT REPORTED OUTCOMES WAS THE LEFT EYE TEARING AT TIMES WHILE EATING. ONGOING NECK SPASMS AND SORENESS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI MATRIXNEURO ADAPTION PLATE 20 HOLES. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10425903 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN ACOUSTIC NEUROMA RESECTION RETROSIGMOID PROCEDURE. THE PATIENT WAS IMPLANTED WITH THE TITANIUM MATRIXNEURO ADAPTATION PLATE AND PUTTY CEMENT. THERE WAS A SURGICAL TIME OF 559 MINUTES. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. THE PATIENT IS DOING GREAT AFTER GROSS TOTAL RESECTION OF A MASSIVE VESTIBULAR SCHWANNOMA AND A SCAR IN THE IAC. THE PATIENT REPORTS LOW BACK PAIN AND ISSUES WITH SLEEPING RECENTLY. PATIENT HAS NO HEARING ON THE RIGHT SIDE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Hearing Impairment; Pain

  MAUDE report 10420129 ↗
• InjuryAug 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN ACOUSTIC NEUROMA RESECTION/CRANIOTOMY AND SURGERY FOR WOUND WASHOUT AND REMOVAL OF HARDWARE. THE ORIGINAL IMPLANTATION DATE WAS UNKNOWN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. THE PROCEDURE OUTCOMES WERE UNKNOWN. THE PATIENT WAS DOING WELL AFTER CRANIOTOMY/RESECTION AND THEN WOUND WASHOUT AND REMOVAL OF HARDWARE. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) TI MATRIXNEURO ADAPTION PLATE 20 HOLES. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10408108 ↗

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