MatrixMANDIBLE 04.503.405.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10887587020433), received between Aug 11, 2020 and Aug 1, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022 FOR TREATING CONDYLAR PROCESS, THE SCREWS IN QUESTION WERE UNABLE TO BE SECURELY TIGHTENED TO A PLATE. THE PROCEDURE WAS COMPLETED WITH REPLACEMENT SCREWS. THERE WERE NO ADVERSE PATIENT OUTCOMES. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 5MM. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15139058 ↗
• MalfunctionAug 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022 FOR TREATING CONDYLAR PROCESS, THE SCREWS IN QUESTION WERE UNABLE TO BE SECURELY TIGHTENED TO A PLATE. THE PROCEDURE WAS COMPLETED WITH REPLACEMENT SCREWS. THERE WERE NO ADVERSE PATIENT OUTCOMES. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 5MM. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15139029 ↗
• MalfunctionAug 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022 FOR TREATING CONDYLAR PROCESS, THE SCREWS IN QUESTION WERE UNABLE TO BE SECURELY TIGHTENED TO A PLATE. THE PROCEDURE WAS COMPLETED WITH REPLACEMENT SCREWS. THERE WERE NO ADVERSE PATIENT OUTCOMES. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 5MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15139023 ↗
• MalfunctionAug 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022 FOR TREATING CONDYLAR PROCESS, THE SCREWS IN QUESTION WERE UNABLE TO BE SECURELY TIGHTENED TO A PLATE. THE PROCEDURE WAS COMPLETED WITH REPLACEMENT SCREWS. THERE WERE NO ADVERSE PATIENT OUTCOMES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 5MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15139015 ↗
• MalfunctionAug 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022 FOR TREATING CONDYLAR PROCESS, THE SCREWS IN QUESTION WERE UNABLE TO BE SECURELY TIGHTENED TO A PLATE. THE PROCEDURE WAS COMPLETED WITH REPLACEMENT SCREWS. THERE WERE NO ADVERSE PATIENT OUTCOMES. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 5MM. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15139005 ↗
• MalfunctionAug 11, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PACKAGE CAME SEALED BUT MISSING THE IMPLANT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10391081 ↗