MatrixMIDFACE 04.503.391Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587020341), received between Aug 19, 2020 and Aug 19, 2020 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K050608); 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 1 most recent of 1 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. PATIENT WAS IMPLANTED WITH AN UNKNOWN BONE PLATES AND CEMENT BONE. THERE WAS NO POST OPERATIVE COMPLICATION PRESENTED. PATIENT REPORTED SEVERE PAIN OVER THE INCISION AT THE OCCIPITAL INCISION AND COULD POINT DIRECTLY TO A TRIGGER POINT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TI MATRIXMIDFACE BOX PLATE 4 HOLES/10MMX10MM/0.7MM THICK. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10426269 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050608. One submission often covers many models, so check the product and lot details in each record.

• Z-2739-2020 · Jun 16, 2020 · Terminated
  MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive proced