MatrixMANDIBLE 03.503.070Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10887587011868), received between Jun 28, 2021 and Jan 11, 2024 — 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.

• MalfunctionJan 11, 2024Break; Break

  IT WAS FURTHER REPORTED THAT NO BROKEN FRAGMENTS RETAINED IN THE PATIENT AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18496053 ↗
• 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) MATRIXMAND/THRX SCRWDRVR BLD S-RETAIN-SH. THIS IS REPORT 3 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18492023 ↗
• 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 MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-SHORT. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18492018 ↗
• 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 MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-SHORT. THIS REPORT IS RELATED TO (B)(4) AND (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18491614 ↗
• MalfunctionAug 31, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE HAND PIECE FOR BATTERY POWERED DRIVER WOULD NOT HOLD A SCREWDRIVER BLADE. WHEN A BLADE IS INSERTED, IT WOULD NOT LOCK-IN AND ENGAGE THE DRIVER. OTHERWISE, THE DRIVER TURNS IT ON AND WORKS FINE. THERE WAS NO DELAY IN SURGERY AND NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A SCREWDRIVER BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12393074 ↗
• MalfunctionJun 28, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT, DURING A ROUTINE INSPECTION IN STERILE PROCESSING, TWO SCREWDRIVER BLADES WERE NOTED TO HAVE BENT PLUS THE DRIVE FINS WOULD NOT RETAIN THE SCREWS PROPERLY. ALSO, THE THREADED DRILL GUIDE FOR MATRIX MANDIBLE APPEARED TO HAVE WORN THREADS AND WOULD NOT PROPERLY ENGAGE THE PLATES. THERE WAS NO KNOWN PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-SHORT. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12077809 ↗
• MalfunctionJun 28, 2021Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT, DURING A ROUTINE INSPECTION IN STERILE PROCESSING, TWO SCREWDRIVER BLADES WERE NOTED TO HAVE BENT PLUS THE DRIVE FINS WOULD NOT RETAIN THE SCREWS PROPERLY. ALSO, THE THREADED DRILL GUIDE FOR MATRIX MANDIBLE APPEARED TO HAVE WORN THREADS AND WOULD NOT PROPERLY ENGAGE THE PLATES. THERE WAS NO KNOWN PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-SHORT. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12077510 ↗