MatrixMANDIBLE 04.503.706Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587022574), received between Feb 21, 2018 and Feb 25, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionFeb 25, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT (B)(6), IT WAS OBSERVED THAT THE TI MATRIXMANDIBLE 20 H ADAPTION PL 1.0 WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE TI MATRIXMANDIBLE 20 H ADAPTION PL 1.0. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13602064 ↗
• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT GOT AN INFECTION AND HAD TO DO A WASH OUT OF MANDIBLE AND REMOVAL OF HARDWARE. SURGEON BELIEVES PATIENT CO-MORBIDITIES MAY HAVE CAUSED THE ISSUE. HARDWARE REMOVED AFTER WASHOUT WAS COMPLETE AND REPLACED WITH NEW HARDWARE. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7286801 ↗