DART-FIRE D1N25012SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840420120434), received between Sep 14, 2023 and Sep 14, 2023 — classified as 1 injury.

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 16, 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.

• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THE PATIENT HAD A SMALL SCREW SYSTEM IMPLANTED IN THE LEFT FOOT. FOURTH LEFT METATARSAL BONE IN THE TOE, PATIENT ENDED UP WITH A RASH, HAD IMPLANT REMOVED 4 YEARS POST-OP BECAUSE SHE COULD BARELY WALKED. THE PATIENT WAS CONTACTED BY THE FDA REQUESTING THE LOT NUMBER OF THE SCREW 9 YEARS AFTER THE INITIAL SURGERY. PATIENT BELIEVES SHE DEVELOPED METAL TOXICITY.

  Patient problems: Ambulation or Postural Difficulties; Cramp(s) /Muscle Spasm(s); Diarrhea; Erythema; Hypersensitivity/Allergic reaction; Metal Related Pathology

  MAUDE report 17750106 ↗