Neodent 104.041Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07898237563619), received between Feb 16, 2023 and Feb 16, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• InjuryFeb 16, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING THE SURGERY THE DENTIST DID NOT FOLLOW THE IFU INSTRUCTION: "BEFORE USING THIS PRODUCT, IT IS RECOMMENDED TO TIE A SAFETY THREAD IN THE HOLE TO AVOID ANY MOVEMENT OR THE RISK OF IT BEING SWALLOWED OR INHALED BY THE PATIENT." THIS WAY, THE SCREWDRIVER HAS DISLOCATED AND WAS SWALLOWED BY THE PATIENT. THE PATIENT WAS SUBMITTED TO A COLONOSCOPY TO REMOVE THE SCREWDRIVER OF THEIR INTESTINE. THE PATIENT DID NOT PRESENT ANY SYMPTOM AND IS DOING WELL AND STABLE, THERE ARE NO FURTHERS INFORMATION ABOUT THE CASE. THE EVENT DID NOT BROUGHT DAMAGES TO THE PATIENT¿S HEALTH, BUT IF RECURS THERE IS POTENTIAL TO CAUSE INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16384278 ↗