MatrixMIDFACE 04.503.396Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587020396), received between Aug 11, 2020 and Aug 11, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 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 UNKNOWN BONE PLATES AND PUTTY CEMENT. IMMEDIATELY AFTER THE SURGERY, THE PATIENT EXPERIENCED SEVERE FACIAL PARALYSIS. THE PATIENT HAD RIGHT MASSETER NERVE TO FACIAL NERVE TRANSFER, AND TEMPORALIS TENDON TRANSFER. THE COMPLICATION WAS RESOLVED. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR 1 TI MATRIXMID FACE ADAPTION PLATE/20 HOLES/0.8MM THICK. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 10391517 ↗

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