MatrixMANDIBLE 04.503.606.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10887587021829), received between Feb 21, 2018 and Aug 18, 2022 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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.

• MalfunctionAug 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING A MANDIBULAR SSRO, THE SCREW WAS NOT ABLE TO BE INSERTED WITH THE SCREWDRIVER. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING REPLACEMENT PRODUCTS. THE SURGEON ASSUMED THAT THE EVENT MIGHT HAVE BEEN TRIGGERED BY THE SCREWDRIVER RATHER THAN THE SCREW. THERE WAS NO REPORTED ADVERSE PATIENT OUTCOME. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 6MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254307 ↗
• MalfunctionJun 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING A SAGITTAL SPLIT RAMUS OSTEOTOMY (SSRO) PROCEDURE TO TREAT MANDIBULAR JAW DEFORMITY, THE SCREW WAS NOT ABLE TO BE TIGHTENED AGAINST A PLATE. ON THE OTHER HAND, A REPLACING SCREW WAS TIGHTENED TO THE SAME PLATE. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 6MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11978685 ↗
• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT GOT AN INFECTION AND HAD TO DO A WASH OUT OF MANDIBLE AND REMOVAL OF HARDWARE. SURGEON BELIEVES PATIENT CO-MORBIDITIES MAY HAVE CAUSED THE ISSUE. HARDWARE REMOVED AFTER WASHOUT WAS COMPLETE AND REPLACED WITH NEW HARDWARE. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7286910 ↗
• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT GOT AN INFECTION AND HAD TO DO A WASH OUT OF MANDIBLE AND REMOVAL OF HARDWARE. SURGEON BELIEVES PATIENT CO-MORBIDITIES MAY HAVE CAUSED THE ISSUE. HARDWARE REMOVED AFTER WASHOUT WAS COMPLETE AND REPLACED WITH NEW HARDWARE. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7286875 ↗
• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT GOT AN INFECTION AND HAD TO DO A WASH OUT OF MANDIBLE AND REMOVAL OF HARDWARE. SURGEON BELIEVES PATIENT CO-MORBIDITIES MAY HAVE CAUSED THE ISSUE. HARDWARE REMOVED AFTER WASHOUT WAS COMPLETE AND REPLACED WITH NEW HARDWARE. (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7286847 ↗
• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT GOT AN INFECTION AND HAD TO DO A WASH OUT OF MANDIBLE AND REMOVAL OF HARDWARE. SURGEON BELIEVES PATIENT CO-MORBIDITIES MAY HAVE CAUSED THE ISSUE. HARDWARE REMOVED AFTER WASHOUT WAS COMPLETE AND REPLACED WITH NEW HARDWARE. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7286825 ↗
• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT GOT AN INFECTION AND HAD TO DO A WASH OUT OF MANDIBLE AND REMOVAL OF HARDWARE. SURGEON BELIEVES PATIENT CO-MORBIDITIES MAY HAVE CAUSED THE ISSUE. HARDWARE REMOVED AFTER WASHOUT WAS COMPLETE AND REPLACED WITH NEW HARDWARE. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7286759 ↗