MatrixMANDIBLE 04.503.410.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587020587), received between Feb 3, 2023 and Feb 3, 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 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.

• MalfunctionFeb 3, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2022, THE SCREW BROKE OFF AS IT WAS THREADED IN, SECURING THE FIXATION PLATE TO THE MANDIBLE. IT WAS IMPOSSIBLE TO REMOVE THE PART SCREWED TO THE BONE. AS A CONSEQUENCE, IT MIGHT BE DIFFICULT TO REMOVE THE PLATE IN THE FUTURE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 10MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16296610 ↗