MatrixMANDIBLE 04.503.702Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587022536), received between May 31, 2018 and May 31, 2018 — classified as 1 injury.

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.

• InjuryMay 31, 2018Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY OCCURRED ON (B)(6) 2018 DUE TO PLATE FAILURE. A MATRIX MANDIBLE MINI PLATE WAS REMOVED DUE TO DEVICE BREAKAGE. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED AND REMOVED. IT WAS FURTHER NOTED THAT THE PATIENT HAD CANCER AND THE MANDIBLE HAD BEEN ORIGINALLY SPLIT TO ADDRESS THE CANCER. IT WAS NOTED THAT THERE WAS AN ISSUE WITH A TOOTH WHICH MAY HAVE CAUSED PRESSURE ON THE PLATE. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN WHAT THE PATIENT WAS REVISED TO. SURGICAL DELAY AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES: SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A MATRIXMANDIBLE MINI PL-TENSION BAND NARROW/2X2H/1.0MM THICK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7558245 ↗