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MatrixMANDIBLE 04.503.741Recalls & reported problems

Synthes GmbH · TI MATRIXMANDIBLE DOUBLE ANGLE RECON PL SMALL 2.5MM THICK · Class 2 · Implant

All models of MatrixMANDIBLE (79)

Data updated Oct 16, 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 10887587022895), received between Nov 14, 2018 and Nov 14, 2018 — 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 16, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionNov 14, 2018Break; Break

    IT WAS REPORTED THAT ON (B)(6) 2018, DURING A FIBULA FREE FLAP FOR MANDIBLE RECONSTRUCTION, A MATRIXMANDIBLE DOUBLE ANGLE PLATE BROKE WHILE BENDING. THE SURGEON USED A NEW PLATE AND RE-BENT THE PLATE TO COMPLETE THE SURGERY. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8071655 ↗

Other PLATE, BONE devices

All PLATE, BONE devices →

Sources and updates

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