MatrixMANDIBLE 03.503.045Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587011714), received between Feb 14, 2023 and Sep 18, 2023 — classified as 2 malfunctions.

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

• MalfunctionSep 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AUGUST 14, 2023, THAT THE PROPLAN GUIDE FOR THE CASE RECOMMENDED A 1.8 DRILL BIT WITH THE DRILL GUIDE FOR THE PRE-DRILL CYLINDERS. THEY HAD OPENED A 1.8 DRILL AND THIS GUIDE. WHEN WE MOUNTED THE DRILL ON THE POWER TOOL (THEY USE A STRYKER HANDPIECE, IF THIS IS RELEVANT), THERE SEEMED TO BE A LOT OF TOGGLE ON THE DRILL BIT WITHOUT A GUIDE BEFORE INSERTING INTO THE TEMPLATE, AND ALSO THE DRILL BIT WAS FAR TOO SHORT WITH THE DRILL GUIDE. SOME OF THESE SCREWS RECOMMENDED WERE 16MM AND 18MM IN LENGTH, AND IF YOU LOOKED AT THE LENGTH OF THE DRILL WHEN PLACED INTO THE GUIDE, IT LOOKED LIKE THE DRILLING LENGTH WOULD REACH A MAXIMUM OF 10MM. THE TWO SURGEONS INVOLVED IN THE CASE WERE UNHAPPY WITH THE AMOUNT OF TOGGLE FIRST ON THE DRILL AND ALSO THAT THE LENGTH DIDN¿T REACH LONG ENOUGH WHEN USING THE GUIDE. THE CASE WENT WELL ENOUGH APART FROM THESE ISSUES. UNFORTUNATELY, THE TUMOR HAD EXTENDED INTO THE MANDIBLE. SO IT HAD TO FREEHAND SOME OF THE LEFT SIDE OF THE MANDIBLE. THE SURGEON MANAGED TO UTILIZE TWO OF THE SCREW HOLES ON THIS SIDE THROUGH THE GUIDE BUT THEN HAD TO BRING IN SOME EXTRA FIBULA AND BURR THE BONE TO ADAPT TO THE PLATE. THERE WERE A FEW MINUTES OF SURGIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765764 ↗
• MalfunctionFeb 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN IRELAND AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL SLEEVE WITH 1.8MM DRILL BIT WAS NOT ABLE TO PASS DOWN THE LOW PROFILE DRILLING SLOTS ON THE MANDIBLE CUTTING GUIDES. HOWEVER, THERE WAS NO ISSUE WITH THE DRILL SLEEVE PASSING THROUGH THE LOW PROFILE SLOTS ON THE FIBULA GUIDE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MATRIXMANDIBLE TROCAR DRILL GUIDE FOR 397.213. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371780 ↗