Affixus® Natural Nail® 47-2496-161-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024505803), received between Jun 23, 2021 and Sep 14, 2026 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Separation Problem

  Patient problems: Pain

  MAUDE report 50755781 ↗
• InjuryNov 7, 2025Migration; Migration

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

  Patient problems: Pain

  MAUDE report 23497345 ↗
• MalfunctionOct 8, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT AN ANN NAIL SURGERY WAS PERFORMED AND AFTER 3 WEEKS FROM THE INITIAL SURGERY, THE SURGEON FOUND THAT ONE OF THE PROXIMAL SCREWS HAD MIGRATED OUT OF THE PROPER POSITION. REVISION SURGERY IS BEING CONSIDERED TO REMOVE THE MIGRATED SCREW. NO DATE HAS BEEN SET FOR RE-OPERATION AT THIS TIME. NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 20398496 ↗
• InjuryAug 22, 2024Separation Problem; Separation Problem

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 20038903 ↗
• InjuryOct 13, 2023Migration; Migration

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 17928694 ↗
• InjuryJun 20, 2023Migration; Migration

  IT WAS REPORTED THAT THE TWO PROXIMAL SCREWS BACKED OUT FROM THE PROPER POSITION ABOUT FOUR (4) MONTHS AFTER THE INITIAL SURGERY. THE SURGEON WILL KEEP AN EYE ON THE PATIENT'S CONDITION. NO REVISION WILL BE PLANNED SO FAR. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 17160280 ↗
• InjuryApr 25, 2023Migration; Migration

  IT WAS REPORTED THAT FOUR MONTHS AFTER INITIAL LEFT HUMERAL NAIL IMPLANTATION ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM ITS PROPER POSITION. NO INTERVENTION IS PLANNED AT THIS TIME. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 16804705 ↗
• InjuryApr 5, 2023Migration; Migration

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

  Patient problems: Failure of Implant

  MAUDE report 16681659 ↗
• InjurySep 6, 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. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 15360559 ↗
• InjuryAug 4, 2021Mechanical Problem; Migration; Mechanical Problem; Migration

  PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND TWO MONTHS FROM THE INITIAL SURGERY IT WAS REPORTED THAT THE FIRST BLUNT SCREW HAD GRADUALLY MIGRATED 2CM FROM THE PROPER POSITION. THE TORQUE DRIVER WAS USED TO ENGAGE THE CORELOCK, FOLLOWED BY NON-TORQUE DRIVER TO TIGHTEN IT MORE. A REVISION SURGERY HAS NOT YET TAKEN PLACE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 12275257 ↗
• MalfunctionJun 23, 2021Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  NO CHANGE TO PREVIOUSLY REPORTED EVENT.

  Patient problems: Failure of Implant; Unspecified Tissue Injury

  MAUDE report 12049021 ↗