Matrix 04.511.401Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587024332), received between Jul 28, 2023 and Jul 28, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ORTHOGNATHIC SURGERY INVOLVING THE UPPER AND LOWER JAW ON (B)(6) 2023. IT HAS BEEN DETERMINED BY THE SURGEON AND ORTHODONTIST THAT THE MAXILLARY SURGERY IS STABLE, HOWEVER, THE MANDIBULAR PORTION IS NOT AND MUST BE REVISED. IMAGING PERFORMED ON AN UNKNOWN DATE SHOWED UNSTABLE FIXATION AND MALOCCLUSION, SO A REVISION SURGERY IS PLANNED FOR THE NEAR FUTURE. THIS REPORT INVOLVES ONE TI MATRIX CURVED SAGITTAL SPLIT PLATE/6 HOLES/6MM BAR. THIS REPORT IS RELATED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17413099 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ORTHOGNATHIC SURGERY INVOLVING THE UPPER AND LOWER JAW ON (B)(6) 2023. IT HAS BEEN DETERMINED BY THE SURGEON AND ORTHODONTIST THAT THE MAXILLARY SURGERY IS STABLE, HOWEVER, THE MANDIBULAR PORTION IS NOT AND MUST BE REVISED. IMAGING PERFORMED ON AN UNKNOWN DATE SHOWED UNSTABLE FIXATION AND MALOCCLUSION, SO A REVISION SURGERY IS PLANNED FOR THE NEAR FUTURE. THIS REPORT INVOLVES ONE TI MATRIX CURVED SAGITTAL SPLIT PLATE/6 HOLES/6MM BAR. THIS REPORT IS RELATED TO (B)(4), (B)(4), (B)(4), AND (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17412912 ↗

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