Affixus® Natural Nail® 47-2486-122-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024505315), received between Jan 20, 2021 and Jun 9, 2025 — classified as 2 injuries.

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

• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL PROCEDURE WITH AFFIXUS HUMERAL NAIL SYSTEM. SUBSEQUENTLY, EXPERIENCED NAIL PROTRUSION WITH IMPINGEMENT SYMPTOMS AND APPROXIMATELY ONE YEAR POST IMPLANTATION UNDERWENT A REVISION SURGERY WHEN THE DEVICE WAS REMOVED. DUE DILIGENCE IS IN PROCESS AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Joint Impingement; Pain

  MAUDE report 22169782 ↗
• InjuryJan 20, 2021Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  INVESTIGATION HAS BEEN COMPLETED AND THE EVENT HAS BEEN UPDATED. EVENT CLARIFICATION RECEIVED THEY HAD TO RE OPERATE THE PATIENT AS THEY THOUGHT THERE WAS SOME NERVE DAMAGE AS THE PATIENT WAS FACING SOME WEAKNESS. HOWEVER UPON EXPLORING THE SURGICAL SITE WHERE THE DISTAL SCREWS WERE INSERTED. THEY OBSERVED THAT THERE WAS SOME BRUISING ON THE RADIAL NERVE AND NO NERVE REPAIR WAS NEEDED TO BE DONE TO THE PATIENT.

  Patient problems: Nerve Damage

  MAUDE report 11201699 ↗