MatrixMANDIBLE 04.503.902Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587023274), received between Apr 24, 2018 and Apr 24, 2018 — 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.

• MalfunctionApr 24, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE DAY PRIOR TO A SCHEDULED SURGERY, THE SURGEON ATTEMPTED TO BEND THE MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATE AND THE PLATE BROKE EASILY. A NEW PLATE WAS USED TO PERFORM THE PROCEDURE THE FOLLOWING DAY. PATIENT/SURGICAL PROCEDURE WAS NOT INVOLVED. CONCOMITANT DEVICES REPORTED: MATRIXMANDIBLE BENDING INSERT (03.503.080, LOT NUMBER UNKNOWN, QUANTITY 1), BENDING INSTRUMENT (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7456402 ↗