PROFYLE 57-13150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540243201), received between Dec 16, 2021 and Dec 16, 2021 — 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 16, 2021Break; Fracture; Break; Fracture

  AS REPORTED: "ON (B)(6)2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO FRACTURE OF THE FIRST TOE BONE. ON (B)(6),2020, THE PATIENT WAS TREATED WITH PLATE COMBINED WITH KIRSCHNER WIRE INTERNAL FIXATION, AND WAS DISCHARGED AFTER IMPROVEMENT. THE DOCTOR ORDERED REGULAR REVIEW IN THE OUTPATIENT DEPARTMENT. ON (B)(6) 2021, THE PATIENT CAME TO THE OUTPATIENT DEPARTMENT OF OUR HOSPITAL DUE TO THE DISCOMFORT OF THE SURGICAL SITE. THE FILM SHOWED THAT THE PLATE WAS BROKEN, AND HE WAS HOSPITALIZED IMMEDIATELY. ON (B)(6), INTERNAL FIXATION WAS REMOVED AND KIRSCHNER WIRE WAS USED FOR INTERNAL FIXATION. POSTOPERATIVE CONDITION IS STABLE. THE INCIDENT LED TO A SECOND OPERATION."

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 13018917 ↗