Affixus® Natural Nail® 47-2496-220-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024505919), received between Dec 21, 2023 and Jan 26, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Separation Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Separation Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL PROCEDURE WITH AN INTRAMEDULLARY NAIL, AFTER WHICH ONE PROXIMAL SCREW BACKED OUT APPROXIMATELY 2 WEEKS POSTOPERATIVELY. THE PATIENT REMAINED UNDER CLINICAL OBSERVATION AND NO REVISION HAS BEEN PLANNED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176236 ↗
• InjurySep 17, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL. ONE WEEK AFTER THE INITIAL SURGERY, SURGEON FOUND ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. TWO WEEKS AFTER THE INITIAL SURGERY, ALL OF THE PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION AND SUBSEQUENTLY UNDERWENT A REVISION SURGERY, DURING WHICH, THE SURGEON CONFIRMED THAT THE CORELOCK HAD BECOME LOOSE. THEN THE SCREW DEPTH WAS READJUSTED, THE CORELOCK WAS RETIGHTENED, AND THE REVISION WAS COMPLETED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23074147 ↗
• InjurySep 10, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT A PATIENT HAD A REVISION SURGERY ONE WEEK AFTER INITIAL IMPLANTATION DUE TO A PROXIMAL SCREW THAT WAS MIGRATED OUT FROM THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND A REVISION SURGERY WAS PERFORMED TO REMOVE THE MIGRATED SCREW. A NEW SCREW WAS ALSO INSERTED AT #1, AND ANOTHER NEW SCREW WAS INSERTED AT #4. DUE DILIGENCE HAS BEEN COMPLETED FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 20179169 ↗
• MalfunctionDec 21, 2023Migration; Migration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18379001 ↗