MatrixMANDIBLE 04.503.435.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587020792), received between Jul 18, 2023 and Jul 18, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Migration” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON ON HIS ORTHOGNATHIC CASES USES THREE SCREWS IN A TRIANGLE INTRAORALLY TO FIXATE THE MANDIBLE ADVANCEMENT ON BOTH SIDES. HE HAS BEEN DOING THIS TECHNIQUE WITH THE SAME DRILL / TAP AND APPROPRIATE SCREWS FOR THE PAST 15 YEARS. NOW HE ADVISED THE SCREWS ARE NOT HOLDING THEY ARE PULLING OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SLIGHT DELAY. THIS REPORT IS FOR ONE (1) 2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 5MM. THIS IS REPORT 3 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344405 ↗
• MalfunctionJul 18, 2023Migration; Migration

  IT WAS REPORTED THAT ON JUNE 26, 2023, THE SURGEON ON HIS ORTHOGNATHIC CASES USES THREE SCREWS IN A TRIANGLE INTRAORALLY TO FIXATE THE MANDIBLE ADVANCEMENT ON BOTH SIDES. HE HAS BEEN DOING THIS TECHNIQUE WITH THE SAME DRILL / TAP AND APPROPRIATE SCREWS FOR THE PAST 15 YEARS. NOW HE ADVISED THE SCREWS ARE NOT HOLDING THEY ARE PULLING OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SLIGHT DELAY. THIS REPORT IS FOR ONE (1) 2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 5MM. THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343985 ↗
• MalfunctionJul 18, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6)2023, THE SURGEON ON HIS ORTHOGNATHIC CASES USES THREE SCREWS IN A TRIANGLE INTRAORALLY TO FIXATE THE MANDIBLE ADVANCEMENT ON BOTH SIDES. HE HAS BEEN DOING THIS TECHNIQUE WITH THE SAME DRILL / TAP AND APPROPRIATE SCREWS FOR THE PAST 15 YEARS. NOW HE ADVISED THE SCREWS ARE NOT HOLDING THEY ARE PULLING OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SLIGHT DELAY. THIS REPORT IS FOR ONE (1) 2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 5MM. THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343983 ↗
• MalfunctionJul 18, 2023Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON ON HIS ORTHOGNATHIC CASES USES THREE SCREWS IN A TRIANGLE INTRAORALLY TO FIXATE THE MANDIBLE ADVANCEMENT ON BOTH SIDES. HE HAS BEEN DOING THIS TECHNIQUE WITH THE SAME DRILL / TAP AND APPROPRIATE SCREWS FOR THE PAST 15 YEARS. NOW HE ADVISED THE SCREWS ARE NOT HOLDING THEY ARE PULLING OUT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SLIGHT DELAY. THIS REPORT IS FOR ONE (1) 2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 5MM. THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343982 ↗