Matrix 04.511.205.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10887587023434), received between Aug 13, 2021 and Feb 12, 2024 — classified as 16 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (8 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024 DURING AN ORTHOGNATHIC PROCEDURE, THE SURGEON USED A DRILL TO INSERT A SCREW. HOWEVER, WHEN THEY TRIED TO INSERT THE SCREW IT SEEMED AS THOUGH THE HOLE WAS NOT LARGE ENOUGH FOR THE SCREW. A SECOND DRILL AND SECOND SCREW WERE TRIED BUT THE SAME RESULT OCCURRED. ON THE THIRD ATTEMPT IT WAS COMPLETED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686063 ↗
• MalfunctionFeb 12, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024 DURING AN ORTHOGNATHIC PROCEDURE, THE SURGEON USED A DRILL TO INSERT A SCREW. HOWEVER, WHEN THEY TRIED TO INSERT THE SCREW IT SEEMED AS THOUGH THE HOLE WAS NOT LARGE ENOUGH FOR THE SCREW. A SECOND DRILL AND SECOND SCREW WERE TRIED BUT THE SAME RESULT OCCURRED. ON THE THIRD ATTEMPT IT WAS COMPLETED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686062 ↗
• 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 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. THIS REPORT IS RELATED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 8 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17413060 ↗
• 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 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. 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 17412911 ↗
• 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 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17412906 ↗
• 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 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. THIS REPORT IS RELATED TO PC-001398610, PC-001398606, PC-001398598, AND PC-001398588, WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 4 OF 10 FOR (B)(4)..

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17412905 ↗
• 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 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. THIS REPORT IS RELATED TO PC-001398610, PC-001398606, PC-001398598, AND (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 9 OF 10 FOR (B)(6)..

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17412904 ↗
• 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 9B)(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 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. THIS REPORT IS RELATED TO PC-001398610, PC-001398606, PC-001398598, AND PC-001398588, WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 6 OF 10 FOR (B)(4)..

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17412902 ↗
• 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 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 7 OF 10 FOR (B)(4)..

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17412899 ↗
• 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 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS. THIS IS REPORT 10 OF 10 FOR (B)(4)..

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17412898 ↗
• InjuryAug 13, 2021Device Slipped; Device Slipped

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL OF AN UNKNOWN ORTHOGNATHIC PLATE AND SCREWS DUE TO ORIGINAL FIXATION WAS LOOSENED CAUSING THE PATIENT OCCLUSION TO SHIFT. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. THIS IS REPORT 8 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12319812 ↗
• InjuryAug 13, 2021Device Slipped; Device Slipped

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL OF AN UNKNOWN ORTHOGNATHIC PLATE AND SCREWS DUE TO ORIGINAL FIXATION WAS LOOSENED CAUSING THE PATIENT OCCLUSION TO SHIFT. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. THIS IS REPORT 7 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12319806 ↗
• InjuryAug 13, 2021Device Slipped; Device Slipped

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL OF AN UNKNOWN ORTHOGNATHIC PLATE AND SCREWS DUE TO ORIGINAL FIXATION WAS LOOSENED CAUSING THE PATIENT OCCLUSION TO SHIFT. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. THIS IS REPORT 5 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12319805 ↗
• InjuryAug 13, 2021Device Slipped; Device Slipped

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL OF AN UNKNOWN ORTHOGNATHIC PLATE AND SCREWS DUE TO ORIGINAL FIXATION WAS LOOSENED CAUSING THE PATIENT OCCLUSION TO SHIFT. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. THIS IS REPORT 3 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12319767 ↗
• InjuryAug 13, 2021Device Slipped; Device Slipped

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL OF AN UNKNOWN ORTHOGNATHIC PLATE AND SCREWS DUE TO ORIGINAL FIXATION WAS LOOSENED CAUSING THE PATIENT OCCLUSION TO SHIFT. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. THIS IS REPORT 6 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12319744 ↗
• InjuryAug 13, 2021Device Slipped; Device Slipped

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL OF AN UNKNOWN ORTHOGNATHIC PLATE AND SCREWS DUE TO ORIGINAL FIXATION WAS LOOSENED CAUSING THE PATIENT OCCLUSION TO SHIFT. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. THIS IS REPORT 2 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12319703 ↗
• InjuryAug 13, 2021Device Slipped; Device Slipped

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL OF AN UNKNOWN ORTHOGNATHIC PLATE AND SCREWS DUE TO ORIGINAL FIXATION WAS LOOSENED CAUSING THE PATIENT OCCLUSION TO SHIFT. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. THIS IS REPORT 4 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12319696 ↗
• InjuryAug 13, 2021Device Slipped; Device Slipped

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL OF AN UNKNOWN ORTHOGNATHIC PLATE AND SCREWS DUE TO ORIGINAL FIXATION WAS LOOSENED CAUSING THE PATIENT OCCLUSION TO SHIFT. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM. THIS IS REPORT 1 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12319667 ↗

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