NA 03.503.039Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10887587011653), received between Feb 1, 2017 and Nov 3, 2025 — classified as 7 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN USING THE PLATE CUTTER, THE TRIGGER BROKE JUST AS THE SPECIALIST HAD FINISHED CUTTING THE PLATE. DUE TO THIS, THERE WAS NO DISCOMFORT ON THE PART OF THE SPECIALIST. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITH NO HARM TO THE PATIENT AND NO ALTERATIONS IN SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452614 ↗
• MalfunctionMar 19, 2025Break; Break

  THE PLATE CUTTER BROKE IN THE MATRIX MIDFACE SET WHEN THE SURGEON WAS TRYING TO CUT THE PLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ANOTHER SET WAS OPENED FOR A CUTTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643550 ↗
• MalfunctionJan 13, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SPRING RUPTURED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR ONE (1) PLATE CUTTER FOR MIDFACE PLATES THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16156858 ↗
• MalfunctionJan 7, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, WHEN USING THE PLIERS TO CUT THE PLATE, A PIECE WAS BROKEN AND COULD NOT BE CLOSED. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) PLATE CUTTER FOR MIDFACE PLATES THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13191500 ↗
• MalfunctionApr 20, 2020Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THE PLATE CUTTER FOR MIDFACE PLATES WAS FOUND NOT FUNCTIONING AS A PIECE OF THE CUTTER IS NOT ATTACHED SO IT WILL NOT CUT ANYTHING. THE ISSUE WAS DISCOVERED DURING RESTOCKING OF THE DEVICE. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE SPRING WITH SLOT HAS BROKEN OFF. THIS PRODUCT CONDITION WAS REASSESSED AND DETERMINED TO BE REPORTABLE ON MARCH 26, 2020. THIS REPORT IS FOR ONE (1) PLATE CUTTER FOR MIDFACE PLATES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9978405 ↗
• MalfunctionJul 24, 2019Break; Break

  UPDATE: 8/6/2019: MEDWATCH TO BE RETRACTED - NON REPORTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8823376 ↗
• MalfunctionFeb 1, 2017Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTED A PLATE CUTTER FOR MIDFACE PLATES IS BROKEN. NO PROCEDURE OR PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6294229 ↗