MatrixMIDFACE 04.503.223.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587019086), received between Jul 4, 2019 and Mar 13, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2024Difficult to Advance; Difficult to Advance

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 14-FEBRUARY-2024 AN UNKNOWN SURGERY FOR A ZYGOMATIC FRACTURE WAS PERFORMED. DURING PLATE FIXATION, THE SCREW IN QUESTION COULD NOT BE FIXED. ANOTHER 4MM SCREW WAS USED AND THE PLATE WAS ABLE TO BE FIXED PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT OUTCOME, THEIR STATUS IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-DRILLING 3MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18895817 ↗
• MalfunctionJun 29, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A SCREW PACKAGING WAS FOUND WITH SCREW CLIP BUT NO SCREW FOUND INSIDE. NO PATIENT OR PROCEDURE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10206043 ↗
• MalfunctionJul 4, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION A PACKAGE WITH AN ORDER NUMBER 56997405, THAT WAS RECEIVED HAD ONE (1) SCREW REMOVED FROM THE PACKAGING. IT LOST SOMEWHERE IN SHIPMENT. THE PACKAGE GOT SMASHED ALONG THE WAY AND THE SCREW GOT SMASHED OUT OF IT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) TI MATRIXMIDFACE SCREW SELF-DRILLING 3MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8762637 ↗

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