MatrixMIDFACE 04.503.210.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587018874), received between Jan 14, 2020 and Jan 14, 2020 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K050608, K083388); 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 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 AN UNKNOWN DATE, THE PATIENT UNDERWENT A REMOVAL OF CRANIOS REINFORCED FAST SET PUTTY, ONE (1)TITANIUM MATRIXNEURO RECONSTRUCTION MESH, ONE (1) 3MM TITANIUM MATRIX MIDFACE SCREW, ONE (1) 10MM TITANIUM MATRIX MIDFACE SCREW, AND ONE (1) 4MM TITANIUM MATRIX MIDFACE SCREW DUE TO C DIFFICILE INFECTION POSTOPERATIVELY. ORIGINAL DATE OF SURGERY WAS ON (B)(6) 2015. THE PATIENT WAS ON A CEPHALEXIN ANTIBIOTIC THERAPY DUE TO COMPLICATION KNOWN ON (B)(6) 2015. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) TI MATRIXMIDFACE SCREW SELF-TAPPING 10MM. THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9587505 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050608, K083388. 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
• Z-2272-2015 · Jun 24, 2015 · Terminated
  Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixati