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Matrix 04.511.224.01Recalls & reported problems

Synthes GmbH · 1.85MM TI MATRIX SCREW SELF-DRILLING/4MM · Class 2 · Implant

All models of Matrix (80)

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 10887587023595), received between Jul 19, 2022 and Jul 19, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

1 other recall cover devices cleared under the same FDA submission (K083388); they may or may not involve this specific model.

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

  • Device-Device Incompatibility1

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.

  • MalfunctionJul 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

    DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEONS WERE IMPLANTING MATRIX ORTHOGNATHIC 1.85MM SCREWS INTO BONE OF POOR QUALITY. THE SCREWS COULD NOT BE PROPERLY TIGHTENED, AND KEPT SPINNING IN THE BONE WITHOUT GAINING PURCHASE. THE SAME SITUATION OCCURRED WITH 1.85MM SELF-DRILLING, SELF-TAPPING, AND 2.1MM EMERGENCY SCREWS. AFTER 10 MINUTES OF DELAY, THE SURGEON DECIDED TO USE ANOTHER SYSTEM TO COMPLETE THE PROCEDURE. THIS REPORT IS FOR A 1.85MM TI MATRIX SCREW SELF-DRILLING/4MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15051601 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083388. One submission often covers many models, so check the product and lot details in each record.

  • Z-2272-2015 · Jun 24, 2015 · Terminated
    Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixati

Other PLATE, BONE devices

All PLATE, BONE devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page