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MatrixMANDIBLE 04.503.412.01Recalls & reported problems

Synthes GmbH · 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 12MM · 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 10887587020631), received between Sep 15, 2023 and Sep 15, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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

  • Manufacturing, Packaging or Shipping Problem1

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 15, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    DEVICE REPORT FROM TAIWAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 28-AUGUST-2023 DURING A NON-SURGICAL PROCEDURE, THE UNOPENED PRODUCT PACKAGE WAS DISCOVERED TO NOT CONTAIN THE IMPLANTS (EMPTY PACKAGE). THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 12MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17759154 ↗

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Sources and updates

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