NA 241.34Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982166821), received between Dec 14, 2017 and Aug 24, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A ONE-THIRD TUBULAR PLATE FOR AN ANKLE FRACTURE ON AN UNKNOWN DATE. CORTEX SCREWS WERE USED FOR FIXATION. SIXTEEN WEEKS POSTOPERATIVELY, HARDWARE WAS REMOVED DUE TO PLATE PROMINENCE. UNION HAD BEEN ACHIEVED AT APPROXIMATELY 12 WEEKS. THIS REPORT INVOLVES ONE ONE-THIRD TUBULAR PLATE WITH COLLAR 4 HOLES/49MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17613119 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR ANKLE FRACTURE WITH A 3.5MM ONE THIRD TUBULAR PLATE AND UNKNOWN CORTEX SCREWS. INTRAOPERATIVELY THERE WAS FRAGMENTATION OF FIBULA, THEREFORE SECOND ONE THIRD TUBULAR PLACED FOR BRIDGING OF FRACTURE. IT WAS NOTED THAT THE COMPLICATION WERE NOT RELATED TO SYNTHES DEVICE. THIS REPORT IS FOR ONE (1) ONE-THIRD TUBULAR PLATE WITH COLLAR 4 HOLES/49MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 17612710 ↗
• InjuryDec 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HARDWARE REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2017 TO REMOVE A ONE-THIRD TUBULAR PLATE WITH COLLAR 4 HOLES/49MM, A LOCKING COMPRESSION PLATE ONE-THIRD TUBULAR PLATE WITH COLLAR 7 HOLES/81MM, EIGHT (4.0MM) CANCELLOUS SCREWS, AND THREE (3.5MM) CORTEX SCREWS. THE INITIAL SURGERY DATE IS UNKNOWN BUT IT WAS FOR A FIBULA FRACTURE. THE HARDWARE REMOVAL WAS DUE TO SOFT TISSUE IRRITATION. THERE WERE NO MALFUNCTIONS WITH THE HARDWARE REMOVED, NO SURGICAL DELAYS AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH PATIENT OUTCOME NOTED AS STABLE. X-RAYS WERE TAKEN BUT UNAVAILABLE TO BE SENT. NO ADDITIONAL IMPLANTS OR MEDICAL INTERVENTIONS WERE PERFORMED ON PATIENT POST HARDWARE REMOVAL. THIS COMPLAINT INVOLVES 13 PARTS. THIS REPORT IS 1 OF 4 FOR (B)(4).

  Patient problems: Irritation; Not Applicable

  MAUDE report 7119034 ↗