MatrixMIDFACE 04.503.223.05Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20887587019090), received between Jan 14, 2020 and Jan 14, 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.

• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF HARDWARE DUE TO INFECTION THAT WAS KNOWN ON (B)(6) 2016. THE ORIGINAL DATE OF THE IMPLANT WAS ON (B)(6) 2016. BONE AND SOFT TISSUE WERE DEBRIDED AND BONE AND HARDWARE WAS REMOVED IN THE LEFT FRONTAL BONE. THE PATIENT HAS A SHEET OF TITANIUM MESH OVER THE CRANIAL DEFECT IN THE LEFT FRONTAL BONE AND HAS PERIODICALLY HAD BREAKDOWN AND HEALING AND BREAKDOWN AND HEALING OVER THIS AREA. IT WAS FELT THAT THEY NEEDED TO EXPLORE THE WOUND, REMOVE SOME OF THE HARDWARE, WASH IT OUT, AND CLOSE IT IN LAYERS AND TRY TO DETERMINE IF THIS WOULD DEFINITIVELY SOLVE THE PROBLEM. THIS REPORT IS FOR ONE (1) TI MATRIXMIDFACE SCREW SELF-DRILLING 3MM. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Impaired Healing; No Code Available; Unspecified Infection

  MAUDE report 9587138 ↗

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