NA 414.040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982212474), received between Nov 30, 2022 and Nov 30, 2022 — 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. 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.

• 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 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15886663 ↗