Matrix 04.511.384Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587024264), received between Sep 27, 2024 and Sep 27, 2024 — classified as 1 injury.

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.

• InjurySep 27, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 A PATIENT WAS HAVING PREVIOUSLY IMPLANTED HARDWARE REMOVED AFTER COMPLAINING OF DISCOMFORT FROM THE HARDWARE. DURING THE REMOVAL, IT WAS DETERMINED THAT THE HARDWARE ON THE RIGHT MAXILLA HAD BROKEN; THE PLATES HAD BROKEN. THIS REPORT IS FOR A TI MATRIX PRE-BENT MAXILLARY PLATE/4MM ADVMNT/0.8MM THK/R.

  Patient problems: Discomfort

  MAUDE report 20323959 ↗

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