MatrixMANDIBLE 04.503.728Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587022765), received between Dec 14, 2023 and Dec 14, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2023Off-Label Use; Device-Device Incompatibility; Off-Label Use; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT AN OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR A STERNAL FRACTURE WAS PERFORMED ON AN UNKNOWN DATE. ALTHOUGH IT WAS AN OFF-LABEL USE, THE PRODUCT WAS USED IN SURGERY AT THE DISCRETION OF THE SURGEON. DURING THE SURGERY, AN EVENT THAT APPEARED TO BE A LOCKING FAILURE OCCURRED. THE SURGEON GAVE UP USING THE PRODUCT AND CHANGED THE PROCEDURE TO A FIXATION USING A WIRE, AND COMPLETED THE SURGERY SUCCESSFULLY WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE TI MATRIXMANDIBLE 6H PLATE 2.0MM THICK. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326288 ↗