MatrixMIDFACE 04.503.323Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587019765), received between Jan 9, 2023 and Jan 9, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2023Break; Break

  THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT STATUS/OUTCOME WAS GOOD.

  Patient problems: Failure of Implant

  MAUDE report 16122098 ↗
• InjuryJan 9, 2023Break; Break

  THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT STATUS/OUTCOME WAS GOOD.

  Patient problems: Failure of Implant

  MAUDE report 16121972 ↗

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