Matrix 04.511.226.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587023632), received between Aug 3, 2022 and Aug 3, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

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

• MalfunctionAug 3, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE CUSTOM MANDIBLE PLATES DID NOT FIT AS EXPECTED, AND THE MATRIX SCREWS IN QUESTION HAD THEIR SCREW HEADS BREAK OFF DURING THE PROCEDURE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A 1.85MM TI MATRIX SCREW SELF-DRILLING/6MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15159715 ↗

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