Affixus® Natural Nail® 47-2486-126-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024505339), received between Nov 23, 2021 and Mar 4, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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.

• InjuryMar 4, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL SYSTEM. AFTER 4 MONTHS FROM THE INITIAL, SURGEON FOUND A SCREW OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THE SURGEON KEEP AN EYE ON THE PATIENT CONDITION AS WELL AS NO REVISION WILL BE PLANNED SO FAR. PATIENT INVOLVEMENT. NO FURTHER OUTCOME.

  Patient problems: Joint Dislocation

  MAUDE report 13666847 ↗
• MalfunctionNov 23, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12859768 ↗