MatrixMIDFACE 04.503.236.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587019321), received between May 22, 2024 and May 22, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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

• MalfunctionMay 22, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE COMPLAINT REGARDING THE 6MM SELF DRILLING MATRIX MIDFACE SCREWS. WHILE DOING A MIDFACE CASE WITH ONE OF THE SURGEONS AND FOUR OF THE 6MM SCREWS BROKE WHILE BEING INSERTED INTO THE PATIENT'S ZF SUTURE. THE SURGEON TRIED TO REMOVE THEM TO REPOSITION THE PLATE BUT ALL FOUR HEADS BROKE OFF. HE ATTEMPTED TO REMOVE THEM BUT WAS UNABLE TO. HE ENDED UP BURRING THEM DOWN, REPOSITIONED THE PLATE AND MOVED ON. ANOTHER SET (MATRIX COMBO) WAS PULLED AND UTILIZED THE SCREWS IN THIS SET WHICH WORKED FLAWLESSLY. SURGERY COMPLETED SUCCESSFULLY, PATIENT STATUS/ OUTCOME IN GOOD STANDING. THIS REPORT IS FOR ONE (1) TI MATRIXMIDFACE EMERGENCY SCREW 6MM. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19374970 ↗
• MalfunctionMay 22, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE COMPLAINT REGARDING THE 6MM SELF DRILLING MATRIX MIDFACE SCREWS. WHILE DOING A MIDFACE CASE WITH ONE OF THE SURGEONS AND FOUR OF THE 6MM SCREWS BROKE WHILE BEING INSERTED INTO THE PATIENT'S ZF SUTURE. THE SURGEON TRIED TO REMOVE THEM TO REPOSITION THE PLATE BUT ALL FOUR HEADS BROKE OFF. HE ATTEMPTED TO REMOVE THEM BUT WAS UNABLE TO. HE ENDED UP BURRING THEM DOWN, REPOSITIONED THE PLATE AND MOVED ON. ANOTHER SET (MATRIX COMBO) WAS PULLED AND UTILIZED THE SCREWS IN THIS SET WHICH WORKED FLAWLESSLY. SURGERY COMPLETED SUCCESSFULLY, PATIENT STATUS/ OUTCOME IN GOOD STANDING. THIS REPORT IS FOR ONE (1) TI MATRIXMIDFACE EMERGENCY SCREW 6MM. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19374956 ↗
• MalfunctionMay 22, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE COMPLAINT REGARDING THE 6MM SELF DRILLING MATRIX MIDFACE SCREWS. WHILE DOING A MIDFACE CASE WITH ONE OF THE SURGEONS AND FOUR OF THE 6MM SCREWS BROKE WHILE BEING INSERTED INTO THE PATIENT'S ZF SUTURE. THE SURGEON TRIED TO REMOVE THEM TO REPOSITION THE PLATE BUT ALL FOUR HEADS BROKE OFF. HE ATTEMPTED TO REMOVE THEM BUT WAS UNABLE TO. HE ENDED UP BURRING THEM DOWN, REPOSITIONED THE PLATE AND MOVED ON. ANOTHER SET (MATRIX COMBO) WAS PULLED AND UTILIZED THE SCREWS IN THIS SET WHICH WORKED FLAWLESSLY. SURGERY COMPLETED SUCCESSFULLY, PATIENT STATUS/ OUTCOME IN GOOD STANDING. THIS REPORT IS FOR ONE (1) TI MATRIXMIDFACE EMERGENCY SCREW 6MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19374932 ↗

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