ProRoot MTA PROROOT5WRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D716PROROOT5W1), received between Sep 14, 2024 and Sep 14, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. How this data works · Data updated Oct 13, 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, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IN THIS EVENT IT IS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION TO THE PRO ROOT MTA 4X0.5GR WHITE THAT WAS USED IN A PROCEDURE. THE PATIENT DEVELOPED THE REACTION AFTER RETURNING HOME FROM THE PROCEDURE. PATIENT SYMPTOMS CONSISTED OF ERYTHEMA AND THROAT DISCOMFORT. THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE THE REMOVAL OF THE PRO ROOT MTA 4X0.5GR WHITE FROM THE ROOT CANAL WAS DONE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20219683 ↗