Matrix 04.511.385Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587024271), received between Jan 22, 2021 and Jan 22, 2021 — 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. How this data works · Data updated Oct 13, 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.

• InjuryJan 22, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION OF ORTHOGNATHIC SURGERY DUE TO TWO BROKEN MAXILLARY PLATES. INITIALLY, THE PATIENT UNDERWENT ORTHOGNATHIC DOUBLE JAW SURGERY FOR SLEEP APNEA IN (B)(6) 2019 AND AFTER SIX MONTHS THE SURGERY, THE PATIENT FELT LIKE HIS FIXATION WEAKENED. THE SURGEON CLAIMS THAT PATIENT "PICKED" AT THE HARDWARE SO THAT IS WHAT COULD HAVE CAUSED THE FAILURE. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES EIGHTEEN (18) DEVICES. THIS REPORT INVOLVES ONE (1) TI MATRIX PRE-BENT MAXILLARY PLATE/6MM ADVMNT/0.8MM THK/L. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11217095 ↗
• InjuryJan 22, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION OF ORTHOGNATHIC SURGERY DUE TO TWO BROKEN MAXILLARY PLATES. INITIALLY, THE PATIENT UNDERWENT ORTHOGNATHIC DOUBLE JAW SURGERY FOR SLEEP APNEA IN (B)(6) 2019 AND AFTER SIX MONTHS THE SURGERY, THE PATIENT FELT LIKE HIS FIXATION WEAKENED. THE SURGEON CLAIMS THAT PATIENT "PICKED" AT THE HARDWARE SO THAT IS WHAT COULD HAVE CAUSED THE FAILURE. IT WAS UNKNOWN IF THE REVISION SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES EIGHTEEN (18) DEVICES. THIS REPORT INVOLVES ONE (1) TI MATRIX PRE-BENT MAXILLARY PLATE/6MM ADVMNT/0.8MM THK/L THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11217089 ↗

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