MatrixMIDFACE 04.503.212.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587018904), received between Aug 2, 2022 and Aug 2, 2022 — classified as 2 malfunctions.

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

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionAug 2, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, SURGEON'S NURSING ASSISTANT ATTEMPTED TO REMOVE MIDFACE SCREWS FOR AN ENDOBROW PATIENT IN PRIVATE ROOM USING INCORRECT DRIVER SHAFT AND HANDLE. THE SCREW HEADS SHEARED OFF. FRAGMENTS WERE GENERATED BUT WERE REMOVED EASILY. SURGEON WAS CALLED TO ROOM TO RETRIEVE USING LONG NEEDLE HOLDERS. THERE WAS UNSPECIFIED AMOUNT OF SURGICAL DELAY DUE TO THE REPORTED EVENT. NO PATIENT CONSEQUENCE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) TI MATRIXMIDFACE SCREW SELF-TAPPING 12MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15149531 ↗
• MalfunctionAug 2, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, SURGEON'S NURSING ASSISTANT ATTEMPTED TO REMOVE MIDFACE SCREWS FOR AN ENDOBROW PATIENT IN PRIVATE ROOM USING INCORRECT DRIVER SHAFT AND HANDLE. THE SCREW HEADS SHEARED OFF. FRAGMENTS WERE GENERATED BUT WERE REMOVED EASILY. SURGEON WAS CALLED TO ROOM TO RETRIEVE USING LONG NEEDLE HOLDERS. THERE WAS UNSPECIFIED AMOUNT OF SURGICAL DELAY DUE TO THE REPORTED EVENT. NO PATIENT CONSEQUENCE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) TI MATRIXMIDFACE SCREW SELF-TAPPING 12MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15149469 ↗

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