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MatrixMANDIBLE 04.503.703Recalls & reported problems

Synthes GmbH · MATRIXMANDIBLE MINI PL-TENSION BAND NRW/3X3H/MALLEABLE/1.0MM · 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587022543), received between Jan 30, 2023 and Jan 30, 2023 — classified as 1 injury.

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

  • Failure of Implant1

Recent adverse event reports

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

  • InjuryJan 30, 2023Break; Break

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PERU AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AFTER PLACING THE PLATE IN ORTHOGNATHIC SURGERY, THE PATIENT RETURNED HOME, AT A CONTROL APPOINTMENT, IT WAS DETECTED THAT THE PLATE WAS BROKEN. REMOVAL SURGERY WAS SCHEDULED FOR THE FOLLOWING WEEK. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TI MATRIXMANDIBLE 20 HOLE ADAPTION PL 1.0MM THICK. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: Failure of Implant

    MAUDE report 16264275 ↗

Other PLATE, BONE devices

All PLATE, BONE devices →

Sources and updates

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