MatrixMANDIBLE 04.503.446.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10887587020976), received between Jul 18, 2023 and Jul 20, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Migration” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2023Device-Device Incompatibility; Migration; Device-Device Incompatibility; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREWS WERE FALLING OUT AND NOT HOLDING. IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 16MM. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17361702 ↗
• MalfunctionJul 20, 2023Device-Device Incompatibility; Migration; Device-Device Incompatibility; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREWS WERE FALLING OUT AND NOT HOLDING. IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 16MM. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17361690 ↗
• MalfunctionJul 20, 2023Device-Device Incompatibility; Migration; Device-Device Incompatibility; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SCREWS WERE FALLING OUT AND NOT HOLDING. IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 16MM. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17361683 ↗
• 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 8 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344509 ↗
• 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 6 OF 10 FOR COMPLAINT(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344411 ↗
• 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 10 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344260 ↗