Affixus® Natural Nail® 47-2486-050-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00889024505490), received between Oct 6, 2020 and Oct 31, 2025 — classified as 12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Migration; Migration

  DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23437342 ↗
• 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 23074155 ↗
• 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 23074027 ↗
• 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 22587079 ↗
• InjuryApr 28, 2025Migration; Migration

  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 21920452 ↗
• InjuryJul 5, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPERATION WITH A PROXIMAL HUMERUS NAIL APPROXIMATELY THREE MONTHS AGO. SIX WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON FOUND #1 AND #3 PROXIMAL SCREWS WERE BACKED OUT FROM THEIR CORRECT POSITION. THE PATIENTS CONDITION WILL BE MONITORED AND NO REVISION IS CURRENTLY PLANNED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE, NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17255672 ↗
• InjuryOct 25, 2022Migration or Expulsion of Device; Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO MIGRATION OF THE SCREW.

  Patient problems: Failure of Implant

  MAUDE report 15665247 ↗
• InjuryOct 14, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO SCREW MIGRATION 3-MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 15602997 ↗
• InjuryOct 14, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION DUE TO SCREW MIGRATION 3-MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 15602996 ↗
• InjuryJul 25, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT HAD A SHOULDER SURGERY, AND APPROXIMATELY 6 MONTHS LATER A REVISION SURGERY WAS DONE DUE TO THE SCREW LOOSENING AND UNSCREWING. THE ANTERIOR OBLIQUE WAS ALSO LOOSE BUT DID NOT UNSCREWED LIKE THE TRANSVERSE ONE. 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 15093005 ↗
• InjuryFeb 23, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL SYSTEM. AFTER 4 WEEKS FROM THE INITIAL, SURGEON FOUND THREE PROXIMAL SCREWS WERE 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13583778 ↗
• InjuryApr 28, 2021Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  NO CHANGE TO PREVIOUSLY REPORTED EVENT.

  Patient problems: Fall; Pain

  MAUDE report 11736851 ↗
• InjuryOct 7, 2020Migration; Migration

  NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10640620 ↗
• InjuryOct 6, 2020Migration; Migration

  PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO BACKED OUT SCREW POST 4 WEEKS OF INITIAL SURGERY.

  Patient problems: No Code Available

  MAUDE report 10633248 ↗