MatrixMIDFACE 04.503.376Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587020198), received between Aug 18, 2020 and Jul 11, 2024 — classified as 3 injuries.

2 other recalls cover devices cleared under the same FDA submission (K050608, 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 3 most recent of 3 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

  A DATA COLLECTION SHEET WAS RECEIVED WHICH INCLUDES SAFETY RELATED DATA ON MATRIX ORTHOGNATHIC. THIS WAS A RETROSPECTIVE CHART REVIEW TO PROVIDE DATA BASED ON DATA USE AGREEMENT WITH JOHNS HOPKINS. IT WAS REPORTED THAT PATIENT RECEIVED FIBULAR OSTEOCUTANEOUS FLAP WITH MICROVASCULAR ANASTOMOSIS, RECONSTRUCTION OF THE RIGHT MIDFACE WITH VOLUME REPLACEMENT AND RECONSTRUCTION OF MAXILLA FOR CRANIOFACIAL RECONSTRUCTION OF BOTH MAXILLA AND MANDIBLE EXPERIENCED INFECTION. PATIENT WAS READMITTED TO HOSPITAL FOR INFECTION TREATMENT BUT NO REOPERATION PERFORMED. THE EVENT IS MARKED AS RELATED TO MO IMPLANTS AND RELATED TO INDEX SURGERY. THIS REPORT IS FOR ONE (1) TI MATRIX MIDFACE ADAPTION PLATE/20 HOLES/0.7MM THICK THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 19722138 ↗
• InjuryAug 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN ACOUSTIC NEUROMA RESECTION RETROSIGMOID PROCEDURE. PATIENT WAS IMPLANTED WITH AN UNKNOWN BONE PLATES AND CEMENT BONE. THERE WAS NO POST OPERATIVE COMPLICATION PRESENTED. PATIENT REPORTED SEVERE PAIN OVER THE INCISION AT THE OCCIPITAL INCISION AND COULD POINT DIRECTLY TO A TRIGGER POINT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TI MATRIXMIDFACE ADAPTION PLATE/20 HOLES/0.7MM THICK THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10426255 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN ACOUSTIC NEUROMA RESECTION RETROSIGMOID PROCEDURE. PATIENT WAS IMPLANTED WITH AN UNKNOWN BONE PLATES AND PUTTY CEMENT. POSTOPERATIVELY, THE PATIENT'S SURGERY WAS COMPLICATED BY SWELLING OF THE NECK WHICH REQUIRED THE PATIENT TO BE KEPT INTUBATED FOR AN EXTRA TWO DAYS FOR AIRWAY PROTECTION. THE PATIENT'S SHOULDER WAS MILDLY WEAK AFTER THE SURGERY AND WAS ATTRIBUTED TO BRACHIAL PLEXUS STRETCH INJURY. THE PATIENT IS MAKING GOOD PROGRESS AND THE POST OPERATIVE COMPLICATIONS WERE RESOLVED. PATIENT'S OUTCOME IS UNKNOWN. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Swelling; Weakness

  MAUDE report 10420805 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050608, K083388. One submission often covers many models, so check the product and lot details in each record.

• Z-2739-2020 · Jun 16, 2020 · Terminated
  MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive proced
• 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