Matrix 04.511.325Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10887587023984), received between Aug 3, 2023 and Jul 11, 2024 — classified as 6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DATA COLLECTION SHEET WAS RECEIVED WHICH INCLUDES SAFETY RELATED DATA ON MATRIX ORTHOGNATHIC. ONE 17-YEAR-OLD FEMALE RECEIVED OSTEOTOMY, LE FORT, WITH MANDIBULAR SAGITTAL SPLIT OSTEOTOMY BILATERAL FOR CRANIOFACIAL RECONSTRUCTION IN MANDIBLE AND EXPERIENCED HARDWARE FAILURE AND INFECTION. THIS EVENT IS MARKED AS RELATED TO MATRIX ORBITAL (MO) IMPLANTS, RELATED TO THE INDEX PROCEDURE AND THE CAUSE FOR REOPERATION. TREATMENT WAS REOPERATION. THIS REPORT INVOLVES ONE TI MATRIX OBLIQUE L-PL/3X3 H MEDIUM/REVERSIBLE/0.7MM THK. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 19722237 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DATA COLLECTION SHEET WAS RECEIVED WHICH INCLUDES SAFETY RELATED DATA ON MATRIX ORTHOGNATHIC. ONE 17-YEAR-OLD FEMALE RECEIVED OSTEOTOMY, LE FORT, WITH MANDIBULAR SAGITTAL SPLIT OSTEOTOMY BILATERAL FOR CRANIOFACIAL RECONSTRUCTION IN MANDIBLE AND EXPERIENCED HARDWARE FAILURE AND INFECTION. THIS EVENT IS MARKED AS RELATED TO MATRIX ORBITAL (MO) IMPLANTS, RELATED TO THE INDEX PROCEDURE AND THE CAUSE FOR REOPERATION. TREATMENT WAS REOPERATION. THIS REPORT INVOLVES ONE TI MATRIX OBLIQUE L-PL/3X3 H MEDIUM/REVERSIBLE/0.7MM THK. THIS IS REPORT 1 OF 3 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 19722109 ↗
• InjuryAug 3, 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 OBLIQUE L-PL/3X3 H MEDIUM/REVERSIBLE/0.7MM THK. 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 17450831 ↗
• InjuryAug 3, 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 OBLIQUE L-PL/3X3 H MEDIUM/REVERSIBLE/0.7MM THK. THIS REPORT IS RELATED TO (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 17450827 ↗
• InjuryAug 3, 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 OBLIQUE L-PL/3X3 H MEDIUM/REVERSIBLE/0.7MM THK. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17450825 ↗
• InjuryAug 3, 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 OBLIQUE L-PL/3X3 H MEDIUM/REVERSIBLE/0.7MM THK. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17450821 ↗

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