NA 414.840Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982213709), received between Jun 16, 2021 and Nov 30, 2022 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT THERE WAS IMPLANT FAILURE AFTER 8 MONTHS POST-OP DUE TO PSEUDARTHROSIS. PLATE BREAKAGE OCCURRED LAST WEEK (RIGHT LEG). PLATE WAS REPLACED TODAY WITH AN EXPERT LFN DIA. 13 MM, L 400 MM. PATIENT WITH LACK OF VITAMIN D. DATE OF REVISION SURGERY (B)(6) 2022). IMPLANT DATE: (B)(6) 2022. EXPLANT DATE: (B)(6) 2022. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?PSEUDARTHROSIS. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THIS REPORT IS FOR ONE (1) UNK - SCREWS: CORTEX. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15886581 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT UNDERWENT A STABILIZATION AND FIXATION OF FRACTURES FOLLOWING A STREET ACCIDENT. THERE WERE NO PROBLEMS IMMEDIATELY POST-OP. THE PATIENT HAD PAIN AND ON (B)(6) 2016 IT WAS OBSERVED THAT THE FRACTURES HAD NOT CONSOLIDATED. IT WAS ADVISED TO REMOVE THE IMPLANTS USED FOR THE FIXATION OF THE FRACTURES AND UNDERGO AN ARTHROSCOPY OF THE KNEE. THE POSITION OF THE FRACTURE FRAGMENTS WERE FOUND TO BE IN A GOOD POSITION. THERE WAS LOCAL INGROWTH OF SCAR TISSUE AND IRREGULARITY OF THE TIBIAL SURFACES, HOWEVER THERE WERE NO MENISCAL LESIONS AND INTACT CRUCIATE LIGAMENTS. THERE WERE NO SIGNS OF ADVERSE REACTIONS AGAINST THE IMPLANTED METAL MATERIAL. FROM 2016 THE PATIENT WAS TREATED WITH HIGH DOSES OF ARCOXIA AND PALEXIA FOR THE SERIOUS PAIN IN THE LEFT KNEE AND RIGHT HIP. THIS REPORT IS FOR ONE (1) 4.5MM TI CORTEX SCREW SELF-TAPPING 40MM. THIS IS REPORT 4 OF 10 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12011295 ↗