Affixus® Natural Nail® 47-2496-240-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00889024505964), received between Jun 4, 2021 and Apr 28, 2025 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT A PATIENT HAD AN INITIAL PROCEDURE WITH THE AFFIXUS HUMERAL NAIL, AFTER WHICH, PRESENTS LIMITED MOVEMENT DUE TO LOOSENING OF TWO SCREWS. PATIENT IS PENDING FOR SCREW REMOVAL ON UNKNOWN DATE. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Loss of Range of Motion

  MAUDE report 21920453 ↗
• InjuryDec 11, 2023Migration; Separation Problem; Migration; Separation Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY DUE TO PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION, APPROXIMATELY ONE (1) MONTH AFTER IMPLANTATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 18307487 ↗
• InjuryApr 26, 2023Migration; Migration

  IT WAS REPORTED THAT ONE MONTH AFTER INITIAL RIGHT 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 16813089 ↗
• InjuryApr 25, 2023Migration; Migration

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 16805469 ↗
• InjuryMar 15, 2023Migration; Migration

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

  Patient problems: Failure of Implant

  MAUDE report 16543925 ↗
• InjuryFeb 27, 2023Patient Device Interaction Problem; Migration; Patient Device Interaction Problem; Migration

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

  Patient problems: Failure of Implant

  MAUDE report 16442292 ↗
• InjuryJun 6, 2022Migration; Migration

  IT WAS REPORTED THAT THE SURGEON FOUND THAT 2 OF THE PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION APPROXIMATELY 1 MONTH AFTER THE IMPLANTATION. THE SURGEON IS KEEPING AN EYE ON THE PATIENT'S CONDITION AND NO REVISION IS PLANNED SO FAR. HARM NOT REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 14601582 ↗
• InjuryApr 28, 2022Patient Device Interaction Problem; Migration; Patient Device Interaction Problem; Migration

  IT WAS REPORTED THAT 5 WEEKS AFTER INITIAL SURGERY, ONE OF THE PROXIMAL SCREWS HAD BACKED OUT FROM THE PROPER POSITION. THE SURGEON IS KEEPING AN EYE ON THE PATIENT CONDITION. NO REVISION SURGERY WILL BE PLANNED SO FAR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 14237396 ↗
• InjuryMar 25, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A REVISION SURGERY DUE TO LOOSENING OF A PROXIMAL SCREW.

  Patient problems: Implant Pain

  MAUDE report 13898773 ↗
• InjuryFeb 15, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL. AFTER 3 WEEKS FROM THE INITIAL, PATIENT STARTED REHABILITATION AGGRESSIVELY. AFTER 4 WEEKS, SURGEON FOUND #1 SCREW OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THEREFORE, REVISION SURGERY WAS PERFORMED AND THE MIGRATED SCREW WAS EXPLANTED. OUTCOME - REVISION DUE TO MIGRATION.

  Patient problems: Failure of Implant

  MAUDE report 13533603 ↗
• MalfunctionJun 21, 2021Mechanical Problem; Migration; Mechanical Problem; Migration

  NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 12031438 ↗
• InjuryJun 8, 2021Mechanical Problem; Migration; Mechanical Problem; Migration

  PATIENT WAS IMPLANTED ON THE RIGHT SIDE. AND 3 WEEKS FROM THE INITIAL SURGERY, THE SURGEON FOUND THAT THE SECOND SCREW OF THE PROXIMAL SCREWS HAD BACKED OUT FROM ITS PROPER POSITION ON THE X-RAY. HENCE, PATIENT UNDERWENT A REVISION SURGERY. DURING THE REVISION SURGERY THE BACKED OUT SCREW WAS EXPLANTED WITHOUT LOOSENING THE CORE LOCK, THE REMAINING SCREWS WERE PERFECTLY LOCKED WITH CORELOCK.

  Patient problems: Insufficient Information; Pain

  MAUDE report 11957631 ↗
• MalfunctionJun 4, 2021Mechanical Problem; Migration; Mechanical Problem; Migration

  PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND 1 MONTH POST IMPLANTATION THE SURGEON FOUND THAT ONE OF THE PROXIMAL SCREWS HAD MIGRATED FROM THE PROPER POSITION. THE REVISION SURGERY IS NOT PLANNED YET.

  Patient problems: Insufficient Information

  MAUDE report 11937732 ↗