MatrixMANDIBLE 04.503.711Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587022628), received between Mar 27, 2023 and Mar 27, 2023 — classified as 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2023Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A SSRO FOR MANDIBLE WAS BEING PERFORMED. THE PLATE IN QUESTION WAS EASILY BROKEN AT THE TIME OF INSERTION WHEN A LITTLE FORCE WAS APPLIED AFTER BENDING IT. A REPLACEMENT PLATE OF THE SAME PRODUCT CODE WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THIS REPORT IS FOR A TI MATRIXMANDIBLE 2X2H CRESCENT PLATE 1.25MM THICK. THIS IS REPORT 1 OF 1 FOR PC(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618518 ↗