MatrixMIDFACE 04.503.343Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587019918), received between Apr 4, 2024 and Apr 4, 2024 — 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. 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.

• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, AFTER A FACIAL FRACTURE CASE, THE SURGEON LEARNED THAT THE PATIENT WAS HAVING VISION ISSUES. THE PRE-OP AND POST-OP VISION WERE INTACT. DURING SURGERY, SYNPOR WAS PLACED TO TREAT THE ORBITAL FLOOR FX. AN ORBITAL RIM TITANIUM PLATE WAS ALSO PLACED. CT IMAGING WAS DONE POST OP. LATE AT NIGHT, THE PATIENT WAS BROUGHT BACK TO THE OR TO REMOVE ORBITAL FLOOR PLATE WITH CONCERN OF A HEMATOMA. SURGEON REPORTED ON 3/19 THAT THE PATIENT HAS LOST VISION. THERE WAS ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY OR IF THERE WERE PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) TI MATRIXMEDF ORBITAL RIM PL/12 H/0.5 THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Inflammation; Loss of Vision

  MAUDE report 19041655 ↗

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