MatrixMIDFACE 04.503.383Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587020266), received between Aug 7, 2020 and Aug 7, 2020 — classified as 1 injury.

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. 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 7, 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 PLATE AND PUTTY CEMENT. POSTOPERATIVELY, THE PATIENT DEVELOPED CSF RHINORRHEA AND WAS HOSPITALIZED FOR MENINGITIS. THE HEAD CT SHOWED PNEUMOCEPHALUS AND CSF RHINORRHEA. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND POST-OPERATIVE COMPLICATIONS WERE RESOLVED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), CRANIOS REINFORCED FAST SET PUTTY 3CC-STERILE (PART# 615.03.01S, LOT# DSB7841, QUANTITY# 1), TI MATRIXMIDFACE H-PLATE 11 HOLES/0.8MM THICK (PART# 04.503.382, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR 1 TI MATRIXMIDFACE OBLIQUE L-PL 2X3 HOLES-LEFT/0.8MM THICK. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 10380145 ↗

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