MatrixMANDIBLE 04.503.742Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587022901), received between Mar 12, 2024 and Sep 23, 2024 — classified as 2 malfunctions.

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

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.

• MalfunctionSep 23, 2024Break; Break

  IT WAS REPORTED ON SEPTEMBER 17 2024, THERE WAS PLATE BREAKAGE BY PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE TI MATRIXMANDIBLE DOUBLE ANGLE RECON PL MEDIUM 2.5MM THICK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278702 ↗
• MalfunctionMar 12, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN MALASIA AS FOLLOWS: IT WAS REPORTED THAT ON FEBRUARY 23, 2024, THE MATRIX MANDIBLE DOUBLE-ANGLED RECON PLATE SNAPPED WHEN THE HEALTH CARE PROVIDER WAS WORKING ON CONTOURING IT PRE-OP. THE SNAPPING POINT WAS ON THE RIGHT ANGLED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE MATRIXMAND RECO-PL DBL-ANGL MED T2.5 TI THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18887602 ↗