NA 224.510Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982158314), received between Jun 29, 2023 and Jun 29, 2023 — 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.

• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ADVERSE EVENT WAS REPORTED FOR STUDY SUBJECT (B)(6) AS FOLLOWS: THE PATIENT SUSTAINED A HIGH ENERGY TRAUMA INJURY ON (B)(6) 2023 RESULTING IN AN OPEN TIBIAL SHAFT FRACTURE. A DISTAL TIBIA PLATE WAS IMPLANTED ON (B)(6) 2023. FOUR PROXIMAL SCREWS AND THREE DISTAL SCREWS WERE USED FOR FIXATION. ON (B)(6) 2023, NONUNION, MALUNION, AND MALALIGNMENT OF THE RIGHT TIBIA WAS NOTED. IMPLANT REMOVAL WAS PERFORMED ON (B)(6) 2023. RECOVERY IS IN PROGRESS. THIS REPORT INVOLVES ONE 4.5MM MEDIAL DISTAL TIBIA PLATE 10 HOLES/197MM-RIGHT. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: Malunion of Bone; Nonunion/Delayed-union Bone Fracture; Physical Asymmetry

  MAUDE report 17224838 ↗