Affixus® Natural Nail® 47-2496-220-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024505902), received between Feb 17, 2021 and Dec 12, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT AN ANN NAIL SURGERY WAS PERFORMED. AFTER 5 MONTHS FROM THE INITIAL SURGERY, THE SURGEON FOUND THAT #2 PROXIMAL SCREW HAD MIGRATED OUT OF THE PROPER POSITION. THE PATIENT COMPLAINED OF PAIN AND REVISION SURGERY WAS PERFORMED TO REMOVE THE MIGRATED SCREW. THE REMOVED SCREW WAS TEMPORARILY RETURNED BUT WAS IMMEDIATELY RETURNED TO THE CUSTOMER. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 20915647 ↗
• InjuryOct 24, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT AN INITIAL OPERATION WAS PERFORMED WITH ANN NAIL SYSTEM AND AFTER 3 WEEKS, SURGEON FOUND TWO OF THE PROXIMAL SCREWS WERE BACKED OUT FROM THE PROPER POSITION. THE SURGEON KEEPS 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: Failure of Implant

  MAUDE report 20522110 ↗
• InjuryJan 30, 2024Migration; Separation Problem; Migration; Separation Problem

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 18606732 ↗
• InjuryFeb 7, 2023Migration; Migration

  IT WAS REPORTED THAT INITIAL SURGERY WAS PERFORMED WITH A NAIL AND APPROXIMATELY 3 MONTHS LATER THE SURGEON FOUND A BACKED OUT PROXIMAL SCREW. NO REVISION OR ADDITIONAL ACTION IS BE PLANNED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 16310893 ↗
• InjuryFeb 17, 2022Mechanical Problem; Mechanical Problem

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

  MAUDE report 13548239 ↗
• InjuryFeb 10, 2022Mechanical Problem; Migration; Mechanical Problem; Migration

  IT WAS REPORTED THAT AFTER 7 WEEKS FROM THE INITIAL, SURGEON FOUND #2 SCREW OF THE PROXIMAL SCREWS WAS BACKED OUT FROM THE PROPER POSITION.

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

  MAUDE report 13505220 ↗
• InjurySep 23, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH ANN NAIL SYSTEM ON AN UNKNOWN SIDE. 11 WEEKS FROM THE INITIAL SURGERY IT WAS OBSERVED THAT THE PROXIMAL SCREWS HAD GRADUALLY BACKED OUT FROM THE ORIGINAL POSITION. HENCE, PATIENT UNDERWENT A REVISION SURGERY DURING WHICH THE BACKED OUT SCREWS WERE EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12518039 ↗
• InjuryAug 4, 2021Mechanical Problem; Migration; Mechanical Problem; Migration

  PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE. AFTER 2 MONTHS FROM INITIAL SURGERY, THE SURGEON OBSERVED THAT THE 3RD SCREW OF THE PROXIMAL SCREWS BACKED OUT FROM THE IMPLANTED POSITION. THE SURGEON KEEPS MONITORING THE PATIENT CONDITION. NO REVISION SURGERY IS PLANNED SO FAR.

  Patient problems: Insufficient Information; Pain

  MAUDE report 12275304 ↗
• InjuryJul 2, 2021Mechanical Problem; Osseointegration Problem; Mechanical Problem; Osseointegration Problem

  PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT A REVISION SURGERY DUE TO PROXIMAL SCREW BACKING OUT(MIGRATION). THE CORELOCK TECHNOLOGY HAD BEEN ENGAGED.

  Patient problems: Insufficient Information; Pain

  MAUDE report 12105549 ↗
• InjuryFeb 17, 2021Patient Device Interaction Problem; Migration

  NO CHANGE TO PREVIOUSLY REPORTED EVENT.

  Patient problems: Insufficient Information; Pain

  MAUDE report 11336510 ↗