MatrixMANDIBLE 03.503.184Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587012476), received between Oct 7, 2021 and Oct 7, 2021 — 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.

• InjuryOct 7, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6 AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6), 2021, A MATRIXMANDIBLE BENDING TEMPLATE BROKE INSIDE THE PATIENT. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE BENDNG TEMPLATE F/2.5MM DBL ANGLE RECON PL/LR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12594626 ↗