Affixus® Natural Nail® 47-2486-128-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024505346), received between Oct 6, 2020 and Mar 4, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Integrity 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 13666846 ↗
• InjuryOct 6, 2020Migration; Migration

  PATIENT WAS IMPLANTED WITH ANN NAIL SYSTEM ON AN UNKNOWN SIDE, A WEEK POST INITIAL SURGERY THE SURGEON NOTICED FROM THE X-RAY THAT ONE OF THE PROXIMAL SCREW HAD BACKED OUT, HENCE A REVISION SURGERY WAS PERFORMED DURING WHICH THE BACKED OUT SCREW WAS REINSERTED.

  Patient problems: No Code Available

  MAUDE report 10634686 ↗