MatrixMIDFACE 03.503.201Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10887587012506), received between Jan 11, 2024 and Mar 28, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE MATRIX SET DRIVERS APPEAR TO BE DULLING AT THE TIP (REDACTED). NO PATIENT INVOLVEMENT AND NO LOT NUMBER AVAILABLE. NO PATIENT INVOLVEMENT,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724498 ↗
• MalfunctionMar 28, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE MATRIX SET DRIVERS APPEAR TO BE DULLING AT THE TIP (REDACTED). NO PATIENT INVOLVEMENT AND NO LOT NUMBER AVAILABLE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724491 ↗
• MalfunctionMar 13, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SETS WERE CONSIGNED AT THE HOSPITAL FOR MORE THAN FEW YEARS. INSTRUMENTS ARE OLD, WORN OFF. DEPTH GAUGE WAS BENT AND GIVING WRONG READINGS. THERE WAS NO PATIENT INVOLVEMENT OR SURGICAL DELAY. EVENT DATE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21597395 ↗
• MalfunctionJan 12, 2024Break; Break

  THE DEPTH GAUGE IS DIFFICULT TO USE AND TO REACH THE CORTICES OF THE BONE. NO FRAGMENTS WERE GENERATED. PATIENT STATUS/ OUTCOME / CONSEQUENCES : NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502297 ↗
• MalfunctionJan 12, 2024Break; Break

  THE DEPTH GAUGE IS DIFFICULT TO USE AND TO REACH THE CORTICES OF THE BONE. NO FRAGMENTS WERE GENERATED.. PATIENT STATUS/ OUTCOME / CONSEQUENCES : NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502296 ↗
• MalfunctionJan 11, 2024Break; Break

  IT WAS REPORTED THAT DURING A CASE, THE SURGEON COMPLAINED ABOUT SOME BROKEN INSTRUMENTS, TO BE REPLACED. THERE WAS NO OTHER INFORMATION PROVIDED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) MATRIXMDF SCRDRVR BLD HEX CPL/S-RETN/52. THIS IS REPORT 6 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18492028 ↗
• MalfunctionJan 11, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING A CASE, THE SURGEON COMPLAINT ABOUT SOME BROKEN INSTRUMENTS THAT NEEDED TO BE REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE MATRIXMIDFACE SCREWDRIVER BLD HEX COUPLING/SELF-RETAIN/52MM. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491636 ↗