Affixus® Natural Nail® 47-2486-054-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024505513), received between Aug 9, 2021 and Sep 17, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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.

• InjurySep 17, 2025Migration; Migration

  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 23074173 ↗
• MalfunctionJul 24, 2025Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY WITH ANN NAIL. SUBSEQUENTLY, 9 DAYS POST IMPLANTATION, SURGEON FOUND THREE OF THE PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION. THE SURGEON WILL KEEP 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586998 ↗
• InjuryNov 25, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  INVESTIGATION RESULTS ARE NOW AVAILABLE.

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

  MAUDE report 12873598 ↗
• InjuryAug 9, 2021Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE. ONE MONTH FROM THE INITIAL SURGERY THE SURGEON NOTICED THAT ONE OF THE PROXIMAL SCREWS HAD MIGRATED FROM ITS POSITION. A REVISION HAS NOT YET TAKEN PLACE. THE TORQUE DRIVER WAS USED TO ENGAGE THE CORELOCK, FURTHERMORE NON-TORQUE DRIVER WAS USED TO TIGHTEN MORE AFTER USING THE TORQUE DRIVER.

  Patient problems: Insufficient Information

  MAUDE report 12294072 ↗