Affixus® Natural Nail® 47-2486-060-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024505544), received between Sep 29, 2020 and Sep 13, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (4 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL SURGERY AND APPROXIMATELY 2 MONTHS POST-OP, REVISION SURGERY WAS PERFORMED DUE TO A SCREW MIGRATION. ONLY THE MIGRATED SCREW WAS EXPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 15409389 ↗
• InjuryJul 21, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PROXIMAL SCREW BACKED OUT FROM THE PROPER POSITION APPROXIMATELY ONE (1) MONTH POST-OP. NO REVISION IS PLANNED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 15072472 ↗
• MalfunctionNov 1, 2021Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12727599 ↗
• InjuryNov 23, 2020Migration; Migration

  PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO SCREWS BACKED OUT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10884192 ↗
• InjurySep 29, 2020Migration; Migration

  PATIENT WAS IMPLANTED WITH AFFIXUS SCREWS ON AN UNKNOWN SIDE. A WEEK POST-SURGERY, THE SURGEON FOUND THAT THREE OF THE PROXIMAL SCREWS HAD BACKED OUT AND HENCE A REVISION SURGERY WAS PERFORMED. IT HAS BEEN OBSERVED THAT THE PROXIMAL SCREWS HAVE FAINT TRACE OF LOCKING WITH THE CORE LOCK SYSTEM WHEREAS THE LAUNCH SCREWS HAD TRACES OF PERFECT LOCKING.

  Patient problems: No Code Available

  MAUDE report 10599582 ↗