MatrixMIDFACE 04.503.204.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10887587018751), received between Sep 26, 2024 and Sep 26, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO REPORTED SURGICAL DELAY. NO MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT WAS IN GOOD CONDITION. NO ISSUE WITH THE SCREWDRIVER WAS IDENTIFIED AS IT PICKED UP OTHER 4MM AND 6MM SCREWS. SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309967 ↗
• MalfunctionSep 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT ORBITAL REPAIR TO EYELID ON SEPTEMBER 23, 2024. SOME MIDFACE ORBITAL SCREWS WERE FAULTY; THEY ARE UNABLE TO LOAD ON TO THE SCREWDRIVER. NO ISSUES PICKING UP THE 6MM SCREWS AND NO ISSUES IN THE PAST. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 4MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309966 ↗
• MalfunctionSep 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO REPORTED SURGICAL DELAY. NO MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT WAS IN GOOD CONDITION. NO ISSUE WITH THE SCREWDRIVER WAS IDENTIFIED AS IT PICKED UP OTHER 4MM AND 6MM SCREWS. SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309964 ↗
• MalfunctionSep 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT ORBITAL REPAIR TO EYELID ON (B)(6) 2024. SOME MIDFACE ORBITAL SCREWS WERE FAULTY; THEY ARE UNABLE TO LOAD ON TO THE SCREWDRIVER. NO ISSUES PICKING UP THE 6MM SCREWS AND NO ISSUES IN THE PAST. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 4MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309868 ↗
• MalfunctionSep 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT ORBITAL REPAIR TO EYELID ON (B)(6) 2024. SOME MIDFACE ORBITAL SCREWS WERE FAULTY; THEY ARE UNABLE TO LOAD ON TO THE SCREWDRIVER. NO ISSUES PICKING UP THE 6MM SCREWS AND NO ISSUES IN THE PAST. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 4MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309859 ↗
• MalfunctionSep 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT ORBITAL REPAIR TO EYELID ON (B)(6) 2024. SOME MIDFACE ORBITAL SCREWS WERE FAULTY; THEY ARE UNABLE TO LOAD ON TO THE SCREWDRIVER. NO ISSUES PICKING UP THE 6MM SCREWS AND NO ISSUES IN THE PAST. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 4MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309857 ↗
• MalfunctionSep 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT ORBITAL REPAIR TO EYELID ON (B)(6) 2024. SOME MIDFACE ORBITAL SCREWS WERE FAULTY; THEY ARE UNABLE TO LOAD ON TO THE SCREWDRIVER. NO ISSUES PICKING UP THE 6MM SCREWS AND NO ISSUES IN THE PAST. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 4MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309855 ↗
• MalfunctionSep 26, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT ORBITAL REPAIR TO EYELID ON SEPTEMBER 23, 2024. SOME MIDFACE ORBITAL SCREWS WERE FAULTY; THEY ARE UNABLE TO LOAD ON TO THE SCREWDRIVER. NO ISSUES PICKING UP THE 6MM SCREWS AND NO ISSUES IN THE PAST. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-TAPPING 4MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309762 ↗

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