Affixus® Natural Nail® 47-2488-000-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024505599), received between Jul 25, 2022 and Jul 25, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 GOT 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 15093020 ↗