Matrix 04.511.461Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587024431), received between Jun 13, 2022 and Jun 13, 2022 — classified as 1 malfunction.

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

• MalfunctionJun 13, 2022Defective Device; Defective Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, MENTON PLATES AND L PLATES (0.8) WERE USED WITH SCREWS FROM ANOTHER COMMERCIAL COMPANY (FIXMEDICAL). THE SPECIALIST INDICATED THAT THE DIAMETERS OF THE SCREWS WERE VERY SMALL AND DECIDED TO COMBINE THE OSTEOSYNTHESIS MATERIALS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A TI MATRIX CHIN PL/DOUBLE BEND 5 HOLES/4MM OFFSET/0.7MM THK. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674449 ↗

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