EXPert Nail 04.031.981SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982094759), received between Jul 10, 2020 and Jul 10, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2020 DUE TO A MISALIGNMENT ISSUE WITH DEVICES. A REPLACEMENT OF AN ADOLESCENT LATERAL FEMORAL NAIL (ALFN) WAS REQUIRED BECAUSE THE BOLT AND TWO (2) HIP SCREWS WERE OUTSIDE OF THE NAIL. THIS MISPLACEMENT RESULTED IN A BAD CONSOLIDATION AND A 51 DEGREE VARUS. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s); Failure of Implant; No Code Available; Pain

  MAUDE report 10257818 ↗