NA 245.99Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982170491), received between May 21, 2022 and Nov 15, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT HAD A REVISION SURGERY DUE TO THE NON UNION OF THE TIBIA. THE PATES WERE REMOVED AND WAS REVISED WITH A NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 2.7MM CALCANEAL RECONSTRUCTION PLATE 9 HOLES/72MM THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 18144391 ↗
• InjuryMay 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REMOVAL OF ANKLE PLATES AND HARDWARE OCCURED. THE SHAFT REMAINED IN THE PATIENT AND THE BROKEN HEAD WAS REMOVED FROM THE PATIENT. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR (1) 2.7 CALC RECONSTRUCTION PL 9 HOLES/72. THIS IS REPORT 2 OF 11 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14467172 ↗
• InjuryMay 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF ANKLE IMPLANTS ON AN UNKNOWN DATE. THE PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A QUARTER-TUBULAR PLATE WITH COLLAR 3 HOLES/23MM. THIS IS REPORT 10 OF 11 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14466676 ↗