MatrixMANDIBLE 04.503.556.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10887587021652), received between Jun 21, 2019 and Feb 21, 2023 — classified as 15 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2023Migration; Migration

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, A PATIENT¿S MMF (MATRIXWAVE) SCREWS PULLED OUT, LEADING TO THE ENTIRE MANDIBLE BEING SKEWED. THERE WAS NO REPORTED PAIN OR OBVIOUS SIGNS OF INFECTION. THE PATIENT REQUIRED A REVISION SURGERY TO REPLACE THE SCREWS, WHICH WAS PERFORMED ON (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16408774 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT COMPLAINED OF ACUTE SWELLING IN THEIR RIGHT CHEEK AND WAS ADMITTED FOR ANTIBIOTICS AND EUA. THE PUS SEEMED TO BE IN THE CHEEK BUT TRACKED FROM THE PLATE. THE PLATE WAS REMOVED AND SOAKED IN PEROXIDE AND BETADINE, IT WAS REQUIRED TO USE SLIGHTLY LARGER SCREWS TO REPLACE THE 6MM SCREWS THAT WERE ORIGINALLY USED. IN THE OR, PRIOR TO BEING ANAESTHETIZED, THE PATIENT COMPLAINED THAT THEIR LEFT SIDE WAS ALSO BECOMING SORE AND THAT THE SKIN ON THAT SIDE WAS STARTING TO POINT. THE MOUTH APPEARS TO HAVE PROOF GRANULATION TISSUE. THIS MEANS THAT ADDITIONAL SCREWS WITH 6-8-10MM LENGTHS WILL NEED TO BE REPLACED WITH EMERGENCY 2.4 SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM. THIS IS REPORT 13 OF 13 FOR (B)(4).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16372947 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT COMPLAINED OF ACUTE SWELLING IN THEIR RIGHT CHEEK AND WAS ADMITTED FOR ANTIBIOTICS AND EUA. THE PUS SEEMED TO BE IN THE CHEEK BUT TRACKED FROM THE PLATE. THE PLATE WAS REMOVED AND SOAKED IN PEROXIDE AND BETADINE, IT WAS REQUIRED TO USE SLIGHTLY LARGER SCREWS TO REPLACE THE 6MM SCREWS THAT WERE ORIGINALLY USED. IN THE OR, PRIOR TO BEING ANAESTHETIZED, THE PATIENT COMPLAINED THAT THEIR LEFT SIDE WAS ALSO BECOMING SORE AND THAT THE SKIN ON THAT SIDE WAS STARTING TO POINT. THE MOUTH APPEARS TO HAVE PROOF GRANULATION TISSUE. THIS MEANS THAT ADDITIONAL SCREWS WITH 6-8-10MM LENGTHS WILL NEED TO BE REPLACED WITH EMERGENCY 2.4 SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM. THIS IS REPORT 12 OF 13 FOR (B)(4).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16372945 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT COMPLAINED OF ACUTE SWELLING IN THEIR RIGHT CHEEK AND WAS ADMITTED FOR ANTIBIOTICS AND EUA. THE PUS SEEMED TO BE IN THE CHEEK BUT TRACKED FROM THE PLATE. THE PLATE WAS REMOVED AND SOAKED IN PEROXIDE AND BETADINE, IT WAS REQUIRED TO USE SLIGHTLY LARGER SCREWS TO REPLACE THE 6MM SCREWS THAT WERE ORIGINALLY USED. IN THE OR, PRIOR TO BEING ANAESTHETIZED, THE PATIENT COMPLAINED THAT THEIR LEFT SIDE WAS ALSO BECOMING SORE AND THAT THE SKIN ON THAT SIDE WAS STARTING TO POINT. THE MOUTH APPEARS TO HAVE PROOF GRANULATION TISSUE. THIS MEANS THAT ADDITIONAL SCREWS WITH 6-8-10MM LENGTHS WILL NEED TO BE REPLACED WITH EMERGENCY 2.4 SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM. THIS IS REPORT 11 OF 13 FOR (B)(4).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16372944 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT COMPLAINED OF ACUTE SWELLING IN THEIR RIGHT CHEEK AND WAS ADMITTED FOR ANTIBIOTICS AND EUA. THE PUS SEEMED TO BE IN THE CHEEK BUT TRACKED FROM THE PLATE. THE PLATE WAS REMOVED AND SOAKED IN PEROXIDE AND BETADINE, IT WAS REQUIRED TO USE SLIGHTLY LARGER SCREWS TO REPLACE THE 6MM SCREWS THAT WERE ORIGINALLY USED. IN THE OPERATING ROOM PRIOR TO BEING ANAESTHETIZED, THE PATIENT COMPLAINED THAT THEIR LEFT SIDE WAS ALSO BECOMING SORE AND THAT THE SKIN ON THAT SIDE WAS STARTING TO POINT. THE MOUTH APPEARS TO HAVE PROOF GRANULATION TISSUE. THIS MEANS THAT ADDITIONAL SCREWS WITH 6-8-10MM LENGTHS WILL NEED TO BE REPLACED WITH EMERGENCY 2.4 SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM. THIS IS REPORT 10 OF 13 FOR (B)(4).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16372943 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT COMPLAINED OF ACUTE SWELLING IN THEIR RIGHT CHEEK AND WAS ADMITTED FOR ANTIBIOTICS AND EUA. THE PUS SEEMED TO BE IN THE CHEEK BUT TRACKED FROM THE PLATE. THE PLATE WAS REMOVED AND SOAKED IN PEROXIDE AND BETADINE, IT WAS REQUIRED TO USE SLIGHTLY LARGER SCREWS TO REPLACE THE 6MM SCREWS THAT WERE ORIGINALLY USED. IN THE OR, PRIOR TO BEING ANAESTHETIZED, THE PATIENT COMPLAINED THAT THEIR LEFT SIDE WAS ALSO BECOMING SORE AND THAT THE SKIN ON THAT SIDE WAS STARTING TO POINT. THE MOUTH APPEARS TO HAVE PROOF GRANULATION TISSUE. THIS MEANS THAT ADDITIONAL SCREWS WITH 6-8-10MM LENGTHS WILL NEED TO BE REPLACED WITH EMERGENCY 2.4 SCREWS. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH/6MM. THIS IS REPORT 9 OF 13 FOR (B)(4).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16372938 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT COMPLAINED OF ACUTE SWELLING IN THEIR RIGHT CHEEK AND WAS ADMITTED FOR ANTIBIOTICS AND EUA. THE PUS SEEMED TO BE IN THE CHEEK BUT TRACKED FROM THE PLATE. THE PLATE WAS REMOVED AND SOAKED IN PEROXIDE AND BETADINE, IT WAS REQUIRED TO USE SLIGHTLY LARGER SCREWS TO REPLACE THE 6MM SCREWS THAT WERE ORIGINALLY USED. IN THE OPERATING ROOM, PRIOR TO BEING ANAESTHETIZED, THE PATIENT COMPLAINED THAT THEIR LEFT SIDE WAS ALSO BECOMING SORE AND THAT THE SKIN ON THAT SIDE WAS STARTING TO POINT. THE MOUTH APPEARS TO HAVE PROOF GRANULATION TISSUE. THIS MEANS THAT ADDITIONAL SCREWS WITH 6-8-10MM LENGTHS WILL NEED TO BE REPLACED WITH EMERGENCY 2.4 SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM. THIS IS REPORT 8 OF 13 FOR (B)(4).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16372937 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT COMPLAINED OF ACUTE SWELLING IN THEIR RIGHT CHEEK AND WAS ADMITTED FOR ANTIBIOTICS AND EUA. THE PUS SEEMED TO BE IN THE CHEEK BUT TRACKED FROM THE PLATE. THE PLATE WAS REMOVED AND SOAKED IN PEROXIDE AND BETADINE, IT WAS REQUIRED TO USE SLIGHTLY LARGER SCREWS TO REPLACE THE 6MM SCREWS THAT WERE ORIGINALLY USED. IN THE OPERATING ROOM, PRIOR TO BEING ANAESTHETIZED, THE PATIENT COMPLAINED THAT THEIR LEFT SIDE WAS ALSO BECOMING SORE AND THAT THE SKIN ON THAT SIDE WAS STARTING TO POINT. THE MOUTH APPEARS TO HAVE PROOF GRANULATION TISSUE. THIS MEANS THAT ADDITIONAL SCREWS WITH 6-8-10MM LENGTHS WILL NEED TO BE REPLACED WITH EMERGENCY 2.4 SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM. THIS IS REPORT 7 OF 13 FOR (B)(4).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16372576 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT COMPLAINED OF ACUTE SWELLING IN THEIR RIGHT CHEEK AND WAS ADMITTED FOR ANTIBIOTICS AND EUA. THE PUS SEEMED TO BE IN THE CHEEK BUT TRACKED FROM THE PLATE. THE PLATE WAS REMOVED AND SOAKED IN PEROXIDE AND BETADINE, IT WAS REQUIRED TO USE SLIGHTLY LARGER SCREWS TO REPLACE THE 6MM SCREWS THAT WERE ORIGINALLY USED. IN THE OR, PRIOR TO BEING ANAESTHETIZED, THE PATIENT COMPLAINED THAT THEIR LEFT SIDE WAS ALSO BECOMING SORE AND THAT THE SKIN ON THAT SIDE WAS STARTING TO POINT. THE MOUTH APPEARS TO HAVE PROOF GRANULATION TISSUE. THIS MEANS THAT ADDITIONAL SCREWS WITH 6-8-10MM LENGTHS WILL NEED TO BE REPLACED WITH EMERGENCY 2.4 SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM. THIS IS REPORT 5 OF 13 FOR (B)(4).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16372573 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT COMPLAINED OF ACUTE SWELLING IN THEIR RIGHT CHEEK AND WAS ADMITTED FOR ANTIBIOTICS AND EUA. THE PUS SEEMED TO BE IN THE CHEEK BUT TRACKED FROM THE PLATE. THE PLATE WAS REMOVED AND SOAKED IN PEROXIDE AND BETADINE, IT WAS REQUIRED TO USE SLIGHTLY LARGER SCREWS TO REPLACE THE 6MM SCREWS THAT WERE ORIGINALLY USED. IN THE OR, PRIOR TO BEING ANAESTHETIZED, THE PATIENT COMPLAINED THAT THEIR LEFT SIDE WAS ALSO BECOMING SORE AND THAT THE SKIN ON THAT SIDE WAS STARTING TO POINT. THE MOUTH APPEARS TO HAVE PROOF GRANULATION TISSUE. THIS MEANS THAT ADDITIONAL SCREWS WITH 6-8-10MM LENGTHS WILL NEED TO BE REPLACED WITH EMERGENCY 2.4 SCREWS. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH/6MM. THIS IS REPORT 2 OF 13 FOR (B)(4).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16372569 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT COMPLAINED OF ACUTE SWELLING IN THEIR RIGHT CHEEK AND WAS ADMITTED FOR ANTIBIOTICS AND EUA. THE PUS SEEMED TO BE IN THE CHEEK BUT TRACKED FROM THE PLATE. THE PLATE WAS REMOVED AND SOAKED IN PEROXIDE AND BETADINE, IT WAS REQUIRED TO USE SLIGHTLY LARGER SCREWS TO REPLACE THE 6MM SCREWS THAT WERE ORIGINALLY USED. IN THE OR, PRIOR TO BEING ANAESTHETIZED, THE PATIENT COMPLAINED THAT THEIR LEFT SIDE WAS ALSO BECOMING SORE AND THAT THE SKIN ON THAT SIDE WAS STARTING TO POINT. THE MOUTH APPEARS TO HAVE PROOF GRANULATION TISSUE. THIS MEANS THAT ADDITIONAL SCREWS WITH 6-8-10MM LENGTHS WILL NEED TO BE REPLACED WITH EMERGENCY 2.4 SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM. THIS IS REPORT 3 OF 13 FOR (B)(4).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16372564 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT COMPLAINED OF ACUTE SWELLING IN THEIR RIGHT CHEEK AND WAS ADMITTED FOR ANTIBIOTICS AND EUA. THE PUS SEEMED TO BE IN THE CHEEK BUT TRACKED FROM THE PLATE. THE PLATE WAS REMOVED AND SOAKED IN PEROXIDE AND BETADINE, IT WAS REQUIRED TO USE SLIGHTLY LARGER SCREWS TO REPLACE THE 6MM SCREWS THAT WERE ORIGINALLY USED. IN THE OR, PRIOR TO BEING ANAESTHETIZED, THE PATIENT COMPLAINED THAT THEIR LEFT SIDE WAS ALSO BECOMING SORE AND THAT THE SKIN ON THAT SIDE WAS STARTING TO POINT. THE MOUTH APPEARS TO HAVE PROOF GRANULATION TISSUE. THIS MEANS THAT ADDITIONAL SCREWS WITH 6-8-10MM LENGTHS WILL NEED TO BE REPLACED WITH EMERGENCY 2.4 SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM. THIS IS REPORT 6 OF 13 FOR (B)(4).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16372538 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT COMPLAINED OF ACUTE SWELLING IN THEIR RIGHT CHEEK AND WAS ADMITTED FOR ANTIBIOTICS AND EUA. THE PUS SEEMED TO BE IN THE CHEEK BUT TRACKED FROM THE PLATE. THE PLATE WAS REMOVED AND SOAKED IN PEROXIDE AND BETADINE, IT WAS REQUIRED TO USE SLIGHTLY LARGER SCREWS TO REPLACE THE 6MM SCREWS THAT WERE ORIGINALLY USED. IN THE OR, PRIOR TO BEING ANAESTHETIZED, THE PATIENT COMPLAINED THAT THEIR LEFT SIDE WAS ALSO BECOMING SORE AND THAT THE SKIN ON THAT SIDE WAS STARTING TO POINT. THE MOUTH APPEARS TO HAVE PROOF GRANULATION TISSUE. THIS MEANS THAT ADDITIONAL SCREWS WITH 6-8-10MM LENGTHS WILL NEED TO BE REPLACED WITH EMERGENCY 2.4 SCREWS. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH/6MM. THIS IS REPORT 4 OF 13 FOR (B)(4).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16372534 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT COMPLAINED OF ACUTE SWELLING IN THEIR RIGHT CHEEK AND WAS ADMITTED FOR ANTIBIOTICS AND EUA. THE PUS SEEMED TO BE IN THE CHEEK BUT TRACKED FROM THE PLATE. THE PLATE WAS REMOVED AND SOAKED IN PEROXIDE AND BETADINE, IT WAS REQUIRED TO USE SLIGHTLY LARGER SCREWS TO REPLACE THE 6MM SCREWS THAT WERE ORIGINALLY USED. IN THE OR, PRIOR TO BEING ANAESTHETIZED, THE PATIENT COMPLAINED THAT THEIR LEFT SIDE WAS ALSO BECOMING SORE AND THAT THE SKIN ON THAT SIDE WAS STARTING TO POINT. THE MOUTH APPEARS TO HAVE PROOF GRANULATION TISSUE. THIS MEANS THAT ADDITIONAL SCREWS WITH 6-8-10MM LENGTHS WILL NEED TO BE REPLACED WITH EMERGENCY 2.4 SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW FINE PITCH / 6MM. THIS IS REPORT 1 OF 13 FOR (B)(4).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 16372346 ↗
• InjuryJun 21, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, A TITANIUM MATRIXMANDIBLE SCREW FINE PITCH THAT WAS PLACED INTO THE MANDIBLE WAS FRACTURED AND BROKEN AFTER SURGERY. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. THE FRACTURED SCREW WAS THEN REMOVED ON (B)(6) 2019 FROM THE PLATE. THE BROKEN SCREW PIECES WERE REMOVED FROM THE PATIENT EASILY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES: TITANIUM MATRIXMANDIBLE 8H STRUT PLATE (PART: 04.503.709, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 2.0 MM TITANIUM (TI) MATRIXMANDIBLE SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8724008 ↗