A.L.P.S.® 8561-35-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887868351815), received between Aug 21, 2025 and Dec 1, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (2 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.

• MalfunctionDec 1, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING INCOMING RECEIVING INSPECTION AT THE DISTRIBUTORSHIP, THE DEVICE WAS FOUND TO BE NON-CONFORMING DUE TO HAVING A BUG-LIKE SUBSTANCE UNDER THE SHRINK PACKAGE. NO PATIENT OR CUSTOMER WAS INVOLVED IN THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23680223 ↗
• MalfunctionNov 21, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A PATIENT HAD AN INITIAL PLATE AND NAIL SYSTEM PROCEDURE. THREE MONTHS POSTOPERATIVELY, ECZEMA DEVELOPED AROUND THE SURGICAL SITE, RAISING SUSPICION OF METAL ALLERGY. CONSEQUENTLY, ALL IMPLANTS WERE REMOVED. THE PATIENT IS LIKELY A POTENTIAL CARRIER OF METAL ALLERGIES. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 23618008 ↗
• InjuryNov 21, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A PATIENT HAD AN INITIAL PLATE AND NAIL SYSTEM PROCEDURE. THREE MONTHS POSTOPERATIVELY, ECZEMA DEVELOPED AROUND THE SURGICAL SITE, RAISING SUSPICION OF METAL ALLERGY. CONSEQUENTLY, ALL IMPLANTS WERE REMOVED. THE PATIENT IS LIKELY A POTENTIAL CARRIER OF METAL ALLERGIES. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 23618000 ↗
• InjuryAug 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

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

  Patient problems: Aseptic loosening; Skin Discoloration

  MAUDE report 22863238 ↗