Matrix 04.511.404Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587024363), received between Apr 29, 2022 and Apr 29, 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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2022 DURING ORTHOGNATHIC SURGERY, DURING THE FIXATION OF MANDIBLE FOLLOWING A BILATERAL SAGITTAL SPLIT OSTEOTOMY PROCEDURE WHILE INSERTING THE SCREW INTO THE PLATE, IT PROTRUDED THROUGH THE INDICATED PLATE HOLE, WHILE ATTEMPTING TO SECURE THE PLATE TO THE BONE. THIS HAPPENED TO THE PLATE ON THE LEFT AND THE RIGHT SIDE OF MANDIBLE DURING FIXATION. PROCEDURE COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) TI MATRIX CRVD SAGITL SPLIT PL/6H/12 BAR. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14251786 ↗

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