Matrix 04.511.423Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587024394), received between Mar 13, 2024 and Mar 13, 2024 — classified as 1 injury.

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. 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.

• InjuryMar 13, 2024Defective Device; Defective Device

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 DURING A REVISION PROCEDURE WITH 3D PRINTED PATIENT-SPECIFIC BSSO PLATES, EVERY TIME THE PLATE WAS PUT ON, THE PATIENT¿S BITE WENT OUT. THE PLATE DIDN¿T MATCH THE CONTOUR. THE SURGEON DISCARDED THE 3D PLATES AND USED STOCK PLATES FROM THE MATRIXORTHOGNATHIC SET. THE PATIENT ENDED UP WITH AN ANTERIOR OPEN BITE, SO THE SURGEON BROUGHT THEM IN AGAIN ON (B)(6) 2024 FOR REVISION SURGERY TO REPOSITION THE PLATE AND ADD NEW SCREWS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI MATRIX SAGITTAL SPLIT PLATE STRAIGHT/4 HOLES/10MM BAR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18896054 ↗

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