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MatrixMANDIBLE 04.503.440.20Recalls & reported problems

Synthes GmbH · 2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 10MM · 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20887587020904), received between Mar 23, 2020 and Mar 23, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device Slipped” (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

  • Device Slipped1

Patient problems

  • Failure of Implant1
  • No Code Available1

Recent adverse event reports

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

  • InjuryMar 23, 2020Device Slipped; Device Slipped

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE MATRIXMANDIBLE PLATE LOOSENING. THE MATRIXMANDIBLE PLATE WAS BENT IN PLACE AND WAS TIGHTENED WITH MORE SCREWS. THE ORIGINAL IMPLANT DATE WAS ON (B)(6) 2020. ONE (1) 04.503.729, ONE (1) 04.503.440 AND THREE (3) 04.503.436 SCREWS WERE IMPLANTED DURING THE INITIAL SURGERY ON (B)(6) 2020. DURING THE REVISION SURGERY THE FOLLOWING SCREWS WERE USED TO TIGHTEN THE PLATE: TWO (2) 04.503.672 AND ONE (1) 04.503.670. THERE WERE NO ADDITIONAL SCREWS IMPLANTED AND ONLY A PART OF THE PLATE WAS REMOVED. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE 2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 10MM. THIS IS REPORT 3 OF 5 FOR (B)(4).

    Patient problems: Failure of Implant; No Code Available

    MAUDE report 9865351 ↗

Other PLATE, BONE devices

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Sources and updates

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