NA 401.156Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20887587046218), received between Apr 27, 2020 and Apr 27, 2020 — classified as 1 injury.

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.

• InjuryApr 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT WAS BEING TEST FOR LICHEN PLANUS AND HEARD OF TITANIUM LEAKING FROM SCREWS. THE SURGEON ASSUMPTION WAS THE 2.0MM CORTEX SCREWS, SELF-TAPPING 8MM TO 18MM LENGTH USED TO SECURE FACIAL IMPLANT IN MANDIBLE OR MIDFACE. UPON NOTIFICATION FROM CUSTOMER WE WENT THE ROUTE OF MEDICAL INFORMATION REQUEST THINKING THE PATIENT WAS INQUIRING ABOUT A FUTURE SURGERY WITH TITANIUM SCREWS BEING IMPLANTED NOT KNOWING THE PATIENT ALREADY THE SCREWS IMPLANTED IN A PREVIOUS SURGERY. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATES: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES TEN (10) DEVICES.

  Patient problems: Hypersensitivity/Allergic reaction; Injury

  MAUDE report 10000303 ↗