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MatrixMANDIBLE 04.503.721Recalls & reported problems

Synthes GmbH · TI MATRIXMANDIBLE 3X3 HOLE ANGLE PLATE 1.5MM THICK · Class 2 · Implant

All models of MatrixMANDIBLE (79)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587022703), received between Sep 7, 2022 and Sep 7, 2022 — classified as 1 malfunction.

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

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 7, 2022Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING AN ORIF PROCEDURE FOR TREATING MANDIBULAR FRACTURE ON (B)(6) 2022, WHEN BENDING THE PLATE IN QUESTION WITH THE HELP OF A BENDER, THE PLATE BROKE OFF. BENDING TOOK PLACE FOR NO LONGER THAN TWO MINUTES. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT. THIS REPORT INVOLVES ONE TI MATRIXMANDIBLE 3X3 HOLE ANGLE PLATE 1.5MM THICK. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15369361 ↗

Other PLATE, BONE devices

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Sources and updates

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