PROFYLE 57-10191Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540242877), received between Dec 1, 2022 and Dec 1, 2022 — classified as 1 injury.

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

• InjuryDec 1, 2022Break; Fracture; Break; Fracture

  AS REPORTED: "ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL BECAUSE OF PAIN AND POOR ACTIVITY IN THE RIGHT FOOT DUE TO FALLING DOWN. IT WAS CONFIRMED THAT 2 AND 4 METATARSAL OF THE RIGHT FOOT OF THE PATIENT FRACTURED. THEN SURGERY WAS PERFORMED TO THE PATIENT. AFTER THE SURGERY, THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WENT TO THE HOSPITAL FOR EXAMINATION REGULARLY . ON (B)(6) 2022, THE PATIENT CAME TO THE HOSPITAL TO REMOVE THE STEEL PLATE. THE PREOPERATIVE RADIOGRAPH SHOWED THAT THE STEEL PLATE WAS BROKEN, AND THE PATIENT DID NOT COMPLAIN ANY OBVIOUS DISCOMFORT. THE DOCTOR THOUGHT THAT THE BONE HEALED WELL AFTER EXAMINATION, AND AGREED TO REMOVE THE PLATE. THE PATIENT IS IN GOOD CONDITION AFTER THE SURGERY OF REMOVAL OF THE PLATE. THE EVENT DID NOT CAUSE HARM TO THE PATIENT."

  Patient problems: Failure of Implant

  MAUDE report 15900416 ↗