MatrixMANDIBLE 03.503.057Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10887587011783), received between Dec 21, 2016 and Mar 20, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Break” (29 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PLATE CUTTER WAS BROKEN IN TWO PIECES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651632 ↗
• MalfunctionAug 14, 2024Corroded; Contamination /Decontamination Problem; Corroded; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHEN HOSPITAL REPROCESSED THE BRAND NEW PLATE CUTTER, FOLLOWING THE PROTOCOL, SOME RUSTING / MARKS ON THE STAINLESS SECTION WERE FOUND. THE PLATE CUTTER IS UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) MATRIXMANDIBLE SHORT CUT PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19984808 ↗
• MalfunctionMay 26, 2022Break; Break

  IT WAS REPORTED ON (B)(6) 2022, THE NURSE REPORTED THAT THE PLATE CUTTER BROKE WHEN CUTTING PLATE ON BACK TABLE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE SHORT CUT PLATE CUTTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14517024 ↗
• MalfunctionMay 18, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THIS WAS A SURGERY USING THE PLATE (04.503.741S) WITH THE SHORTCUT FOR MATRIXMANDIBLE IN QUESTION ON (B)(6) 2022. IN THE SURGERY, SHORT CUT WAS BROKEN WHILE CUTTING A PLATE ON A TABLE. CUTTING WAS PERFORMED 2 ~ 3 TIMES, AND THE BREAKAGE OCCURRED IN THE FINAL ADJUSTMENT OF THE PLATE SIZE. THE DAMAGED PART IS NEAR THE PIN INSERTION PART TO GRASP THE PLATE DURING CUTTING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: MATRIXMAND RECO-PL DBL-ANGL SM T2.5 TI (PART: 04.503.741S; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES ONE DEVICE SHORTCUT F/MATMAND-PL T1.5-2.8 W/RASP IN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14429564 ↗
• MalfunctionJan 5, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, PLATE- BENDERS BOTH ARE BREAK OFF SIMULTANEOUSLY WHILE TRYING TO BEND A PLATE. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THERE WAS NO FRAGMENT GENERATED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - PLATES: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) MATRIXMANDIBLE SHORT CUT PLATE CUTTER. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13167922 ↗
• MalfunctionJan 5, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, PLATE- BENDERS BOTH ARE BREAK OFF SIMULTANEOUSLY WHILE TRYING TO BEND A PLATE. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THERE WAS NO FRAGMENT GENERATED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - PLATES: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) MATRIXMANDIBLE SHORT CUT PLATE CUTTER. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13167916 ↗
• MalfunctionNov 12, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MATRIXMANDIBLE COMBINATION BENDER, MATRIXMANDIBLE SHORT CUT PLATE CUTTER, BONE REDUCTION FORCEPS, MATRIXMANDIBLE SCREWDRIVER BLADE, GRAPHIC CASES FOR MATRIX MIDFACE, INSTRUMENT TRAY FOR MATRIX MIDFACE AND DRILL BIT AND BLADE MODULE FOR MATRIX MIDFACE ARE BROKEN AND OR OLDER THAT DOES NOT FUNCTION WELL FOUND IN THE STORAGE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (10) DEVICES. THIS REPORT IS FOR (1) MATRIXMANDIBLE SHORT CUT PLATE CUTTER. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805748 ↗
• MalfunctionOct 28, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INSPECTION OF FIELD EQUIPMENT, ONE OF THE PLATE CUTTERS AND DRILL GUIDES WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) MATRIXMANDIBLE SHORT CUT PLATE CUTTER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12710848 ↗
• MalfunctionMay 17, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE OF A RIB, ON (B)(6) 2021, THE TWO (2) PLATE BENDERS WERE NOT CUTTING PLATES ADEQUATELY. INSTEAD OF A CLEAN CUT, THE PLATE CUTTERS WERE TORTIONING AND BENDING THE PLATE. NO FURTHER INFORMATION PROVIDED. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICES IT WAS IDENTIFIED THAT THE CUTTING HEAD JAWS OF BOTH THE CUTTERS WERE DULL AND DEFORMED. THIS PRODUCT CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2021. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE SHORT CUT PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832054 ↗
• MalfunctionApr 6, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A MANDIBULAR ORIF TUMOR SURGERY. DURING THE SURGERY, A PART OF THE PLATE CUTTER BROKE WHEN CUTTING THE PLATE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - PLATES: MATRIXMANDIBLE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE SHORT CUT PLATE CUTTER. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624840 ↗
• MalfunctionJan 6, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE INSTRUMENT BROKE DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER INSTRUMENT. THERE WAS NO SURGICAL DELAY OR ADVERSE HARM TO THE PATIENT REPORTED. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE SHORT CUT PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11125147 ↗
• MalfunctionMay 29, 2020Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE MAINTENANCE INSPECTION OF THE MATRIX MANDIBLE SET ON (B)(6) 2020, ONE OF THE MATRIX MANDIBLE SHORT CUT PLATE CUTTERS WAS DROPPED AND BROKE. THERE WERE NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A MATRIX MANDIBLE SHORT CUT PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10100897 ↗
• MalfunctionMay 19, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT DURING A DEMONSTRATION, THE MATRIXMANDIBLE SHORT CUT PLATE CUTTER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) MATRIXMANDIBLE SHORT CUT PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10070753 ↗
• MalfunctionMay 1, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING MAXILLOFACIAL SURGERY ON (B)(6) 2020, MATRIXMANDIBLE SHORT CUT PLATE CUTTER BROKE WHILE CUTTING THE PLATE. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: PLATE (PART # UNKNOWN, LOT UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE SHORT CUT PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10019091 ↗
• MalfunctionApr 22, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF LOANER SET IT WAS OBSERVED THAT THE MATRIXMANDILE SHORT CUT PLATE CUTTER WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE CUTTING HEAD JAWS ARE DEFORMED. THIS PRODUCT CONDITION WAS REASSESSED AND DETERMINED TO BE REPORTABLE ON APRIL 3, 2020. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE SHORT CUT PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9988199 ↗
• MalfunctionMar 4, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT 1 OF 2 SHORTCUT FOR MATRIX MANDIBLE PLATE CUTTERS ARE BROKE IN HALF WHILST CUTTING THE PLATE. AN OLD SHORTCUT PLATE CUTTER FROM A 2.4 UNILOCK SET WAS SUBSTITUTED AND CUT THE PLATE FINE. THERE WAS NO REPORTED DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 9788134 ↗
• MalfunctionFeb 21, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE SHORT CUT PLATE CUTTERS (03.503.057) WERE BROKEN DURING A RECONSTRUCTION SURGERY FOR A MANDIBULAR. THE SURGERY WAS COMPLETED BY USING A TRAUMA PLATE WITH A 30 MINUTE SURGICAL DELAY. CONCOMITANT DEVICE: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE MATRIXMANDIBLE SHORT CUT PLATE CUTTER. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9738479 ↗
• MalfunctionFeb 21, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THAT THE SHORT CUT PLATE CUTTERS (03.503.057) WERE BROKEN DURING A RECONSTRUCTION SURGERY FOR A MANDIBULAR. THE SURGERY WAS COMPLETED BY USING A TRAUMA PLATE WITH A 30 MINUTE SURGICAL DELAY. CONCOMITANT DEVICE: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), THIS REPORT IS FOR ONE MATRIXMANDIBLE SHORT CUT PLATE CUTTER. THIS IS REPORT 1 OF 2 FOR (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9738469 ↗
• MalfunctionNov 7, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE MATRIXMANDIBLE SHORT CUT PLATE CUTTER WAS CUTTING AN UNKNOWN PLATE AND JUST BROKE IN HALF. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9291823 ↗
• MalfunctionNov 6, 2019Break; Break

  THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. IT WAS DETERMINED THIS REPORT IS A DUPLICATE OF COMPLAINT (B)(4). ALL INFORMATION WILL BE CAPTURED ON MANUFACTURER REPORT NUMBER 2939274-2019-62008.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9285885 ↗
• MalfunctionJul 17, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019, DURING INSPECTION OF FIELD EQUIPMENT MATRIX MANDIBLE SET, THE MATRIXMANDIBLE SHORT CUT PLATE CUTTER WAS NOTICED TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE SHORT CUT PLATE CUTTER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8799985 ↗
• MalfunctionJun 26, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, ON THE STERILE BACK TABLE THE SURGEON WAS USING THE MATRIXMANDIBLE PLATE CUTTERS TO CUT AN UNKNOWN 2.8MM MANDIBLE RECONSTRUCTION/MATRIXMANDIBLE PLATE. ONE OF THE MATRIXMANDIBLE PLATE CUTTER BROKE IN HALF. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN MATRIXMANDIBLE PLATE (PART #: UNKNOWN, LOT#: UNKNOWN QUANTITY #1). THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE SHORT CUT PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8737244 ↗
• MalfunctionApr 30, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE RIBS. A RATCHETING SCREWDRIVER HANDLE AND A SCREWDRIVER BLADE WERE STUCK TOGETHER, AND A MATRIXMANDIBLE SHORT CUT PLATE CUTTER WAS CHIPPED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE SHORT CUT PLATE CUTTER. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8565013 ↗
• MalfunctionJan 24, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE OF A MATRIXMANDIBLE SHORT CUT PLATE CUTTER BROKE WHILE ATTEMPTING TO CUT AN UNKNOWN 2.8MM THICK RECONSTRUCTION PLATE. THE CUTTER WAS NOT FULLY CEDED ON THE PLATE CAUSING TOO MUCH PRESSURE IN THE HANDLE AND MAKING IT BRAKE. THE PLATE WAS CUT CORRECTLY. THE ITEM WAS REMOVED FROM THE SET AND IS NO LONGER IN USE. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM REPORTED. PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: 2.8MM THICK RECONSTRUCTION PLATE (PART# UNKNOWN, LOT# UNKNOWN, QTY 1). THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE SHORT CUT PLATE CUTTER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8274273 ↗
• MalfunctionMar 12, 2018Break; Break

  IT WAS REPORTED THAT WHILE THE SALES CONSULTANT WAS REVIEW HIS FIELD EQUIPMENT SETS HE NOTED THAT THE MATRIX MANDIBLE PLATE CUTTER IS BROKEN IN TWO PIECES. ISSUE WAS DISCOVERED WHILE PUTTING SETS TOGETHER. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE SHORT CUT PLATE CUTTER. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7331655 ↗