MatrixMANDIBLE 03.503.036Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10887587011622), received between Dec 27, 2021 and Jun 9, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Break

  IT WAS REPORTED THAT THE MATRIX ORTHOGNATIC DEPTH GAUGE WAS BROKEN. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25445427 ↗
• MalfunctionSep 9, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENT WAS UNABLE TO STERILIZE/ASSEMBLE. THERE WAS CHIPPING AND CRACKING. IT WAS UNABLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009879 ↗
• MalfunctionSep 9, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE INSTRUMENT WAS UNABLE TO STERILIZE/ASSEMBLE. THERE WAS CHIPPING AND CRACKING. IT WAS UNABLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009873 ↗
• MalfunctionSep 5, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE DEPTH GAUGE IN THE MATRIXMANDIBLE SET WAS JAMMED. A FIX WAS ATTEMPTED SEVERAL TIMES AND IT WAS DETERMINED THAT THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22983825 ↗
• MalfunctionMar 13, 2025Incorrect Measurement; Material Deformation; Illegible Information; Incorrect Measurement; Material Deformation; Illegible Information

  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 21597112 ↗
• MalfunctionFeb 18, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT DURING A CURETTAGE OSTEITIS MANDIBLE AND OSTEOSYNTHESIS WHEN THE DEVICE WAS IN CONTACT WITH THE PATIENT THE METAL (INNER) ROD OF THE DEPTH GAUGE NO LONGER HOLDS THE BONE. UNABLE TO MEASURE SCREW. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399785 ↗
• MalfunctionNov 19, 2024Break; Break

  IT WAS REPORTED, THAT ON NOVEMBER 11 2024. THE DEPTH GAUGE WAS BROKEN. THERE WAS NO PATIENT CONSEQUENCE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724109 ↗
• 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) MATRIXMANDIBLE DEPTH GAUGE. THIS IS REPORT 10 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491678 ↗
• 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) MATRIXMANDIBLE DEPTH GAUGE. THIS IS REPORT 2 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491628 ↗
• MalfunctionSep 26, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE WAS BENT. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE DEPTH GAUGE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821924 ↗
• MalfunctionApr 24, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, IT WAS NOTED THAT THERE WAS WEAR AND TEAR OF THE ITEMS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MATRIXMANDIBLE DEPTH GAUGE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16795221 ↗
• MalfunctionDec 27, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT MATRIXMANDIBLE DEPTH GAUGE WAS MISSING A COMPONENT. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE DEPTH GAUGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087372 ↗