Affixus® Natural Nail® 47-2496-160-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024505773), received between Jun 8, 2021 and Mar 30, 2026 — classified as 6 injuries, 2 malfunctions.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Malposition of Device

  IT WAS REPORTED FROM A RETROSPECTIVE CLINICAL STUDY THAT A PATIENT HAD AN INITIAL INTRAMEDULLARY NAILING OF THE RIGHT HUMERUS. SUBSEQUENTLY, THE PATIENT UNDERWENT REMOVAL OF ALL HARDWARE APPROXIMATELY 7 MONTHS LATER DUE TO NAIL PROMINENCE. X-RAYS REVEALED RADIOLOGICAL PROTRUSION WITHOUT CLINICAL SYMPTOMS. THE PATIENT REMAINED SATISFIED THROUGHOUT THE STUDY, AND THE BONE HAD HEALED PRIOR TO EXPLANTATION. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24720093 ↗
• MalfunctionJul 1, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL SURGERY WITH ANN NAIL SYSTEM. SUBSEQUENTLY, 42 DAYS POST IMPLANTATION, SURGEON FOUND THAT 3 PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION. THE SURGEON KEEPS AN EYE ON THE PATIENT CONDITION AS WELL AS NO REVISION WILL BE PLANNED SO FAR. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22370765 ↗
• InjuryJan 8, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT AN ANN NAIL SURGERY WAS PERFORMED. AFTER 1 MONTH FROM THE INITIAL SURGERY, THE SURGEON FOUND THAT 3 PROXIMAL SCREWS HAD MIGRATED OUT OF THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND REVISION SURGERY WAS PERFORMED. IN THE REVISION SURGERY, THE SCREWS THAT HAD COME LOOSE WERE REINSERTED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 21105998 ↗
• InjurySep 15, 2023Migration; Migration

  IT WAS REPORTED THAT AFTER A YEAR POST RIGHT-SIDE IMPLANTATION SURGEON FOUND ONE OF THE SCREWS BACKED OUT FROM THE PROPER POSITION. REVISION SURGERY WAS PERFORMED FIVE MONTHS LATER TO REMOVE THE MIGRATED SCREW. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17754137 ↗
• InjuryApr 25, 2023Migration; Migration

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 16804868 ↗
• InjuryMay 18, 2022Migration; Migration

  IT WAS REPORTED THAT ONE OF THE PROXIMAL SCREWS BACKED OUT FROM THE PROPER POSITION ONE WEEK AFTER INITIAL IMPLANTATION. THE SURGEON IS KEEPING AN EYE ON THE PATIENT'S CONDITION. NO REVISION SURGERY PLANNED SO FAR. NO HARM REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 14433193 ↗
• InjuryFeb 23, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL SYSTEM. AFTER 4 WEEKS FROM THE INITIAL, SURGEON FOUND THREE PROXIMAL SCREWS WERE 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 problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13583785 ↗
• InjuryJun 8, 2021Mechanical Problem; Migration or Expulsion of Device; Migration; Mechanical Problem; Migration or Expulsion of Device; Migration

  NO EVENT UPDATE. INVESTIGATION RESULTS ARE AVAILABLE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 11957629 ↗