MatrixMANDIBLE 04.503.406.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587020488), received between Jul 7, 2022 and Dec 2, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025, THE SCREW BROKE OFF DURING IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693237 ↗
• MalfunctionJul 7, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS FOUND THAT THE SCREWHEAD ON THE SCREW HAD BROKEN. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT SCREW, NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 6MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14943607 ↗