MatrixMIDFACE 04.503.234.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587019260), received between Oct 14, 2024 and Oct 14, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (1 report).

1 other recall cover devices cleared under the same FDA submission (K050608); 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 16, 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.

• InjuryOct 14, 2024Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT NASAL RECONSTRUCTIVE SURGERY. ONE SYNTHES, L-SHAPE AND ONE SYNTHES, STRAIGHT 0.5MM, MULTI-HOLE TITANIUM MINI PLATES WERE USED IN HER SURGERY. ONE OF THE MINI-PLATES WAS SCREW FIXATED TO THE RIGHT NASAL BONE WITH THE MINI-PLATE EXTENDING SUBCUTANEOUSLY TO THE RIGHT EXTERNAL NASAL VALVE/NOSTRIL, FOR SUPPORT OF THE RIGHT INTERNAL AND EXTERNAL VALVES. THE OTHER MINI-PLATE WAS SUTURE-SECURED TO THE CARTILAGINOUS DORSAL AND CAUDAL NASAL SEPTUM, SUBMUCOSALLY, FOR SUPPORT OF THE NASAL DORSUM AND TIP. THE PATIENT DID WELL POSTOPERATIVELY UNTIL APPROXIMATELY DECEMBER OF 2020, WHEN EXCESSIVE MOBILITY OF THE RIGHT SIDE MINI-PLATE AT THE SCREW FIXATION SITES ON THE RIGHT NASAL BONE WAS DISCOVERED. REVISION SURGERY WITH RE-FIXATION OF THE RIGHT SIDE MINI-PLATE TO THE NASAL BONE WAS PERFORMED ON (B)(6), 2021. THE PATIENT DID WELL WITH NORMAL, COMFORTABLE BREATHING UNTIL MAY 2024, WHEN THE RIGHT SIDE NASAL OBSTRUCTION RECURRED DUE TO VALVE COLLAPSE. THE PATIENT SUBSEQUENTLY UNDERWENT DENTAL X-RAYS FOR A SEPARATE ISSUE THAT REVEALED MINI-PLATE DISCONTINUITIES. DETAILED X-RAYS OF THE NASAL BONES WERE OBTAINED ON JUNE 11, 2024, SHOWING COMPLET

  Patient problems: Obstruction/Occlusion

  MAUDE report 20439978 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050608. 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