NA 04.005.518Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982085863), received between Nov 17, 2020 and Dec 23, 2025 — 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 18, 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.

• InjuryDec 23, 2025Migration; Migration

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2025 DUE TO OSTEOMYELITIS. PATIENT ALSO PRESENTED WITH EXPOSURE OF THE SCREWS IN THE ANKLE CAUSING SOFT TISSUE INJURY. THE PATIENT REMAINS UNDER MANAGEMENT FOR IRRIGATION AND EVALUATION FOR POSSIBLE AMPUTATION DEPENDING ON THE EVOLUTION OF THEIR VASCULAR CONDITION. DATE OF IMPLANT: (B)(6) 2024. DATE OF EXPLANT: (B)(6) 2025.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 23875824 ↗
• InjuryJul 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, PATIENT UNDERWENT A REVISION OF A TIBIAL SHAFT FRACTURE HYPERTROPHIC NON-UNION. THE HARDWARE WAS REMOVED WITHOUT COMPLICATIONS AND REVISED. ALL IMPLANTS WERE INTACT UPON REMOVAL NOTHING WAS BROKEN. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT WAS DOING FINE POST-OPERATIVELY. THERE WERE NO COMORBIDITIES FOR THE PATIENT. THE ORIGINAL DATE OF SURGERY WAS ON THE (B)(6) 2019. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILS. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12116471 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON OCTOBER 21, 2020, PATIENT UNDERWENT PARTIAL REMOVAL OF ONE (1) TITANIUM LOCKING SCREW 36MM, ONE (1) TITANIUM LOCKING SCREW 28MM AND ONE (1) TITANIUM END CAP DUE TO MALUNION, REVISION WITH TIBIAL ROTATIONAL OSTEOTOMY. ONE (1) UNKNOWN TIBIAL NAIL AND TWO (2) UNKNOWN SCREWS WERE NOT REMOVED. THE PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: Impaired Healing; No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10854503 ↗