Valor® 415101120LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840420125583), received between Nov 7, 2021 and Feb 14, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDNESS AND SWELLING LOWER LEG AND ANKLE. IT WAS ALSO NOTED THAT THE IM NAIL LOOSENED AND CAUSED INFECTION THAT LED TO A NONUNION OF THE ANKLE FUSION SITE. IT REQUIRED REMOVAL OF THE IM NAIL WITH BONE BIOPSIES AND PLACEMENT OF ABX CEMENT NAIL. IN ADDITION TO THAT THE PATIENT WAS GIVEN IV ANTIBIOTICS FOR 6 WEEKS FOLLOWED WITH REVISION OF ANKLE FUSION WITH EXTERNAL FIXATOR.

  Patient problems: Inflammation; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 13524844 ↗
• InjuryNov 7, 2021Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY TO REMOVE THE NAIL. ALLEGEDLY, THE COMPRESSION SCREW IN THE NAIL WAS DEFECTIVE WHICH MADE IT IMPOSSIBLE TO SCREW THE EXTRACTOR ONTO THE NAIL TO EXTRACT THE NAIL CORRECTLY. THE SURGEON MADE TWO ADDITIONAL INCISIONS AT THE TIBIA THAT WERE NOT PLANNED TO REMOVE THE NAIL. THIS RESULTED IN THE SURGERY LASTING FOR 3 HOURS INSTEAD OF 45 MINUTES. IT ALSO RESULTED IN 3 MONTHS OF CONVALESCENCE INSTEAD OF 2 WEEKS.

  Patient problems: Insufficient Information

  MAUDE report 12763301 ↗