Affixus® Natural Nail® 47-2486-034-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00889024505414), received between Jun 23, 2021 and Jul 1, 2025 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025Migration; Migration

  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 22370760 ↗
• MalfunctionJul 1, 2025Migration; Migration

  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 22370748 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL PROCEDURE WITH AFFIXUS HUMERAL NAIL SYSTEM. SUBSEQUENTLY, EXPERIENCED NAIL PROTRUSION WITH IMPINGEMENT SYMPTOMS AND APPROXIMATELY ONE YEAR POST IMPLANTATION UNDERWENT A REVISION SURGERY WHEN THE DEVICE WAS REMOVED. DUE DILIGENCE IS IN PROCESS AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Joint Impingement; Pain

  MAUDE report 22169774 ↗
• InjuryAug 15, 2024Migration; Migration

  IT WAS REPORTED THAT AFTER 2 MONTHS FROM THE INITIAL SURGERY, THE SURGEON FOUND THAT THE #1 AND #3 PROXIMAL SCREWS HAD MIGRATED OUT OF THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND REVISION SURGERY WAS PERFORMED TO REMOVE THE MIGRATED SCREWS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME

  Patient problems: Failure of Implant; Pain

  MAUDE report 19994324 ↗
• MalfunctionFeb 26, 2024Migration; Migration

  DILIGENCE IS COMPLETE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 18778344 ↗
• InjuryOct 13, 2023Migration; Migration

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 17928697 ↗
• InjuryJun 22, 2023Migration; Migration

  IT WAS REPORTED THAT FOUR (4) WEEKS AFTER IMPLANTATION OF SHOULDER NAIL, ONE OF THE PROXIMAL SCREWS HAS BACKED OUT FROM PROPER POSITION. IT IS NOT KNOWN WHICH ONE EXACTLY BACKED OUT. NO REVISION IS PLANNED SO FAR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 17179700 ↗
• InjuryDec 19, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL RIGHT SHOULDER SURGERY. APPROXIMATELY 2 MONTHS LATER, REVISION SURGERY WAS PERFORMED DUE TO SCREW MIGRATION. 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 16003190 ↗
• InjuryNov 22, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE SURGEON FOUND THAT THE PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION FIVE (5) MONTHS AFTER THE INITIAL SURGERY. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT'S CONDITION. REVISION SURGERY IS NOT CURRENTLY PLANNED. NO FURTHER PATIENT OUTCOME WAS PROVIDED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15841855 ↗
• InjurySep 27, 2022Migration; Migration

  IT WAS REPORTED THAT A SCREW BACKED OUT FROM ITS PROPER POSITION TWO WEEKS 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

  MAUDE report 15492858 ↗
• InjurySep 27, 2022Migration; Migration

  IT WAS REPORTED THAT THE SCREW BACKED OUT FROM ITS PROPER POSITION TWO WEEKS 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

  MAUDE report 15492798 ↗
• 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 13898851 ↗
• InjuryJan 12, 2022Migration or Expulsion of Device; Human-Device Interface Problem; Migration or Expulsion of Device; Human-Device Interface Problem

  IMPLANT MIGRATION - BLUNT SCREW BACKED OUT: IT WAS REPORTED THAT AFTER 2 WEEKS FROM THE IMPLANTATION, SURGEON FOUND #1 SCREW OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13237006 ↗
• InjuryAug 5, 2021Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  PATIENT WAS IMPLANTED WITH ANN NAIL SYSTEM ON AN UNKNOWN SIDE. A MONTH AFTER THE INITIAL SURGERY, THE SURGEON NOTICED THAT ONE OF THE PROXIMAL SCREW HAD MIGRATED FROM ITS POSITION. THE SURGEON IS MONITORING THE PATIENT'S CONDITION AND A REVISION SURGERY HAS NOT YET BEEN PLANNED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 12280478 ↗
• InjuryAug 4, 2021Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 12272836 ↗
• 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

  PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE. AFTER 6 WEEKS FROM THE SURGERY THE PROXIMAL SCREW GET LOOSE AND OUT THE NAIL DAMAGING ARM SOFT TISSUES. NO REVISION SURGERY WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 12049026 ↗