MatrixMIDFACE 03.503.205Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587012537), received between Mar 19, 2019 and Aug 19, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT THE SURGERY WITH THE SCREWS AND THE SCREWDRIVER. DURING THE SURGERY, THE SURGEON COULDN¿T HOLD THE SCREW WITH THE SCREWDRIVER, AND HE COULDN¿T INSERT THE SCREW. EVENTUALLY, THE SURGEON COULDN'T INSERT THE SCREW COMPLETELY. THE SURGERY WAS COMPLETED WITH LESS THAN 30 MINUTES DELAY. AFTER THE SURGERY, WHEN THE SURGEON TRIED TO HOLD OTHER SCREWS WITH THE SAME SCREWDRIVER, HE COULD HOLD THEM WITHOUT ANY PROBLEM. THIS REPORT IS FOR ONE (1) MATRIXMIDFACE SCREWDRIVER BLD W/SPRG HLDG SLV SHRT/79MM HXC. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10426928 ↗
• MalfunctionAug 19, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT THE SURGERY WITH THE SCREWS AND THE SCREWDRIVER. DURING THE SURGERY, THE SURGEON COULDN¿T HOLD THE SCREW WITH THE SCREWDRIVER, AND HE COULDN¿T INSERT THE SCREW. EVENTUALLY, THE SURGEON COULDN'T INSERT THE SCREW COMPLETELY. THE SURGERY WAS COMPLETED WITH LESS THAN 30 MINUTES DELAY. AFTER THE SURGERY, WHEN THE SURGEON TRIED TO HOLD OTHER SCREWS WITH THE SAME SCREWDRIVER, HE COULD HOLD THEM WITHOUT ANY PROBLEM. THIS REPORT IS FOR ONE (1) MATRIXMIDFACE SCREWDRIVER BLD W/SPRG HLDG SLV SHRT/79MM HXC. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10426809 ↗
• InjuryMar 19, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE IN (B)(6) 2018, PATIENT WAS IMPLANTED WITH THREE MANDIBLE PLATES. ONE OF THE THREE PLATES IMPLANTED BECAME INFECTED, AND PATIENT WISHED FOR THEM TO BE REMOVED. ON AN UNKNOWN DATE, PATIENT UNDERWENT HARDWARE REMOVAL PROCEDURE. DURING THE REMOVAL SURGERY, SURGEON NOTED THAT DURING THE INITIAL IMPLANT PROCEDURE, AN OLDER SYSTEMS INSTEAD OF LATEST MATRIX LINE WAS USED. AS PER THE SURGEON, THIS IS A PUBLIC SAFETY ISSUE AS NOT ALL HOSPITALS IN THE AREA HAVE THE OLDER SET AVAILABLE. SYNTHES CRANIOFACIAL MODULAR FIXATION SYSTEM & MANDIBLE MODULAR FIXATION SYSTEM WERE USED TO INITIALLY PLACE THE IMPLANTS. DURING THE REMOVAL SURGERY, SURGEON HAD THE UNIVERSAL SCREW REMOVAL SET, AS WELL AS A MATRIXMANDIBLE SCREWDRIVER AT HIS DISPOSAL. THE UNKNOWN SCREW WAS STRIPPED. HE CLAIMS THE PROVIDED DRIVERS, AND BLADES WERE NOT THE APPROPRIATE INSTRUMENTS, AND DOES NOT BELIEVE THE IT SHOULD BE ALLOWED TO USE AN OLDER SYSTEM, WHEN IT IS NOT READILY AVAILABLE TO ALL LOCAL HOSPITALS. IT WAS FURTHER REPORTED THAT THERE WAS NO ALLEGATION OR MALFUNCTION WITH THE SCREWS WERE MENTIONED, JUST THAT THE PROPER SCREWDRIVER BLADE WAS NOT AVAILABLE, MAKING THEIR REMOVAL MORE DIFFICU

  Patient problems: No Code Available

  MAUDE report 8433600 ↗