MatrixMANDIBLE 04.503.642.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10887587022215), received between Oct 5, 2022 and Oct 7, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  DEVICE REPORT FROM BRAZIL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 THE SURGEON REMOVED THE IMPLANTS FROM THE FIRST SURGERY AS THE IMPLANTS WERE DAMAGED INSIDE THE PATIENT. NO INFORMATION IS KNOWN ON PATIENT STATUS. THIS REPORT IS FOR A 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM. THIS IS REPORT 7 OF 9 FOR (B)(4).

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15562633 ↗
• InjuryOct 7, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  DEVICE REPORT FROM BRAZIL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 THE SURGEON REMOVED THE IMPLANTS FROM THE FIRST SURGERY AS THE IMPLANTS WERE DAMAGED INSIDE THE PATIENT. NO INFORMATION IS KNOWN ON PATIENT STATUS. THIS REPORT IS FOR A 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM. THIS IS REPORT 4 OF 9 FOR (B)(4).

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15562590 ↗
• InjuryOct 7, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  DEVICE REPORT FROM BRAZIL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 THE SURGEON REMOVED THE IMPLANTS FROM THE FIRST SURGERY AS THE IMPLANTS WERE DAMAGED INSIDE THE PATIENT. NO INFORMATION IS KNOWN ON PATIENT STATUS. THIS REPORT IS FOR A 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM. THIS IS REPORT 5 OF 9 FOR (B)(4).

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15562589 ↗
• InjuryOct 7, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  DEVICE REPORT FROM BRAZIL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 THE SURGEON REMOVED THE IMPLANTS FROM THE FIRST SURGERY AS THE IMPLANTS WERE DAMAGED INSIDE THE PATIENT. NO INFORMATION IS KNOWN ON PATIENT STATUS. THIS REPORT IS FOR A 2.4 MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12 MM. THIS IS REPORT 6 OF 9 FOR (B)(4).

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15562566 ↗
• InjuryOct 5, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED (B)(6) 2022 THE SURGEON REMOVED THE IMPLANTS FROM THE FIRST SURGERY AS THE IMPLANTS WERE DAMAGED INSIDE THE PATIENT. NO INFORMATION IS KNOWN ON PATIENT STATUS. THIS IS REPORT 3 OF 3 FOR (B)(4). THIS REPORT IS FOR 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 15544198 ↗