MatrixMANDIBLE 03.503.079Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587011929), received between Aug 20, 2018 and Apr 9, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A MATRIX MANDIBLE CUTTER MISSING A RASP ON THE SIDE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR A MATRIXMANDIBLE SMALL PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19075423 ↗
• MalfunctionApr 2, 2024Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENTS WERE RETURNED TO THE DISTRIBUTION CENTER ON (B)(6) 2024, AFTER A MARGINAL MANDIBULECTOMY FOR OSTEOMYELITIS SURGERY PERFORMED ON (B)(6) 2024. IT WAS CONFIRMED AT THE DISTRIBUTION CENTER THAT THE PLATE CUTTER ACCESSORY RUBBER WAS NOT RETURNED. THE RUBBER IS A NON-REMOVABLE PART. THE PLATE CUTTER WAS NOT USED FOR THE SURGERY. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE SMALL PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028600 ↗
• MalfunctionJun 17, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING OSTEOSYNTHESIS PROCEDURE FOR TRAUMA, THE SCREW ON THE CUTTING PLIERS FOR MATRIXMANDIBLE PLATES WAS BROKEN DURING THE CUTTING PROCESS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING OTHER CUTTING PLIERS. THERE WAS NO SIGNIFICANT DELAY. PATIENT OUTCOME WAS WELL AND NO HARM WAS REPORTED. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE SMALL PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704797 ↗
• MalfunctionAug 20, 2018Break; Break

  IT WAS REPORTED THAT WHEN CLEANING THE MATRIXMANDIBLE PLATE CUTTERS AT THE STERILE PROCESSING DEPARTMENT ON (B)(6) 2018, THE TENSION BAND BROKE OFF OF THE CUTTER. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT. THIS REPORT IS FOR A MATRIXMANDIBLE SMALL PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7797042 ↗