Affixus® Natural Nail® 47-2496-161-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024505827), received between Dec 15, 2020 and May 20, 2026 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Separation Problem” (6 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.

• MalfunctionMay 20, 2026Separation Problem

  IT WAS REPORTED THAT TWO PROXIMAL SCREWS OF AN INTRAMEDULLARY NAIL BACKED OUT APPROXIMATELY TWO MONTHS POSTOPERATIVELY. THE PATIENT WAS MONITORED AND NO REVISION WAS PLANNED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25237083 ↗
• InjuryDec 26, 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 21021134 ↗
• InjuryOct 28, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT AN ANN NAIL SURGERY WAS PERFORMED AND AFTER ONE MONTH FROM THE INITIAL SURGERY, THE SURGEON FOUND THAT A PROXIMAL SCREW HAD MIGRATED OUT OF THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND REVISION SURGERY WAS PERFORMED TO REMOVE THE MIGRATED SCREW. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 20547431 ↗
• MalfunctionMar 21, 2024Separation Problem; Separation Problem

  NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 18949345 ↗
• InjuryMar 18, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL, AFTER 8 MONTHS FROM THE INITIAL, SURGEON FOUND #1 PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND A REVISION SURGERY WAS PERFORMED TO REMOVE THE MIGRATED SCREW. DILIGENCE IS COMPLETED AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Pain

  MAUDE report 18924484 ↗
• InjuryDec 21, 2023Migration; Separation Problem; Migration; Separation Problem

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 18380053 ↗
• InjuryOct 12, 2023Migration; Migration

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 17918283 ↗
• InjuryJun 13, 2023Migration; Migration

  IT WAS REPORTED THAT AFTER TWO WEEKS AFTER THE INITIAL SURGERY, TWO PROXIMAL SCREWS BACKED OUT FROM THE PROPER POSITION. THE SURGEON WILL MONITOR THE PATIENT'S CONDITION. NO REVISION HAS BEEN PLANNED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

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

  MAUDE report 17115985 ↗
• InjuryAug 4, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH ANN NAIL. AFTER 2 MONTHS FROM THE INITIAL SURGERY, THE SURGEON FOUND 2 PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15161932 ↗
• InjuryApr 19, 2022Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH NAIL. AFTER 2 MONTH FROM THE INITIAL, SURGEON FOUND #1 SCREW OF THE PROXIMAL SCREWS WAS 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: Insufficient Information

  MAUDE report 14140005 ↗
• MalfunctionDec 15, 2020Device-Device Incompatibility; Device-Device Incompatibility

  NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

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

  MAUDE report 11015132 ↗