Affixus® Natural Nail® 47-2496-221-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024505933), received between Jul 26, 2021 and Aug 15, 2024 — classified as 5 injuries, 1 malfunction.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2024Separation Problem; Separation Problem

  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 19994491 ↗
• InjuryJun 20, 2024Separation Problem; Separation Problem

  IT WAS REPORTED PATIENT UNDERWENT REVISION APPROXIMATELY 4 WEEKS FROM THE INITIAL SURGERY, SURGEON FOUND ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND A REVISION WAS PERFORMED TO REMOVE THE MIGRATED SCREW. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19579343 ↗
• MalfunctionJun 5, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH (B)(6). AFTER 8 WEEKS POST-IMPLANTATION, SURGEON FOUND ONE OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION. THE SURGEON WILL KEEP AN EYE ON THE PATIENT CONDITION AS WELL, AS NO REVISION HAS BEEN PLANNED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 19470351 ↗
• InjuryFeb 9, 2023Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO (2) WEEKS AFTER INITIAL SURGERY, THE SURGEON FOUND ONE OF THE PROXIMAL SCREW WAS BACKED OUT FROM THE PROPER POSITION. REVISION SURGERY IS NOT PLANNED, AND THE PATIENT'S CONDITION WILL CONTINUE TO BE MONITORED. 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 16331866 ↗
• InjuryFeb 23, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT OPERATION WAS PERFORMED WITH ANN NAIL SYSTEM. AFTER 2 MONTHS FROM THE INITIAL, SURGEON FOUND A 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 13583791 ↗
• InjuryJul 26, 2021Mechanical Problem; Migration; Mechanical Problem; Migration

  NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12223776 ↗