MatrixMIDFACE 04.503.228.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587019208), received between Sep 24, 2018 and Oct 5, 2023 — 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 16, 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.

• MalfunctionOct 5, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN SURGERY WAS PERFORMED FOR THE HUMERUS ON (B)(6) 2023. DURING THE SURGERY, THE 8MM SCREW¿S HEAD BROKE WHEN IT WAS TIGHTENED WHILE FIXING THE PLATE. THE HEADS OF TWO ADDITIONAL SCREWS, 6MM TO 4MM, ALSO BROKE OFF. THE SHAFTS REMAINED IN THE PATIENT¿S BODY. THERE IS A POSSIBILITY THAT THE FRONT AND BACK OF THE PLATE WERE INSERTED INCORRECTLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE; THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. IT WAS CONFIRMED THAT THERE WAS NO ALLEGATION AGAINST THE PLATE. THIS REPORT INVOLVES ONE TI MATRIXMIDFACE SCREW SELF-DRILLING 8MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17876383 ↗
• MalfunctionSep 24, 2018Break; Break

  IT WAS REPORTED PATIENT UNDERWENT A CRANIOTOMY WITH INSERTION OF ELECTRODE ARRAY ON (B)(6) 2018. WHILE THE SURGEON AS INSERTING ONE (1) 6MM AND TWO (2) 8MM MATRIXMIDFACE SCREWS INTO THE HOUSING FOR THE ARRAY, THE SCREW HEAD CAME OFF. THE REMAINING PORTION OF THE SCREW REMAINS EMBEDDED IN PATIENT¿S BONE. SURGERY WAS COMPLETED SUCCESSFULLY WITH AN UNSPECIFIED DELAY. CONCOMITANT DEVICE REPORTED: NON-SYNTHES ELECTRODE ARRAY (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 6MM MATRIXMIDFACE SCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7904344 ↗

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