MatrixMANDIBLE 04.503.408.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10887587020532), received between Jul 28, 2021 and Sep 18, 2023 — classified as 6 malfunctions.

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

• MalfunctionSep 18, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE SCREWDRIVER BLADES IN QUESTION WERE NOT STAYING ENGAGED WITH THE 8MM 2.0 MANDIBLE SCREWS AND WOULD STRIP WHEN ATTEMPTING TO SEAT THE SCREWS. THERE WAS NO REPORTED PATIENT OR PROCEDURE IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 8MM. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17767450 ↗
• MalfunctionSep 18, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE SCREWDRIVER BLADES IN QUESTION WERE NOT STAYING ENGAGED WITH THE 8MM 2.0 MANDIBLE SCREWS AND WOULD STRIP WHEN ATTEMPTING TO SEAT THE SCREWS. THERE WAS NO REPORTED PATIENT OR PROCEDURE IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 8MM. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17767448 ↗
• MalfunctionSep 18, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE SCREWDRIVER BLADES IN QUESTION WERE NOT STAYING ENGAGED WITH THE 8MM 2.0 MANDIBLE SCREWS AND WOULD STRIP WHEN ATTEMPTING TO SEAT THE SCREWS. THERE WAS NO REPORTED PATIENT OR PROCEDURE IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 8MM. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17767445 ↗
• MalfunctionSep 18, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE SCREWDRIVER BLADES IN QUESTION WERE NOT STAYING ENGAGED WITH THE 8MM 2.0 MANDIBLE SCREWS AND WOULD STRIP WHEN ATTEMPTING TO SEAT THE SCREWS. THERE WAS NO REPORTED PATIENT OR PROCEDURE IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 8MM. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17767443 ↗
• MalfunctionAug 3, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE CUSTOM MANDIBLE PLATES DID NOT FIT AS EXPECTED, AND THE MATRIX SCREWS IN QUESTION HAD THEIR SCREW HEADS BREAK OFF DURING THE PROCEDURE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 8MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15159801 ↗
• MalfunctionJul 28, 2021Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS INVOLVING A TOTAL OF 1 ACTUAL DEVICES FOR BROKEN SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12242295 ↗