Neodent 109.788Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07898237569963), received between Nov 9, 2017 and Mar 15, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (4 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN THE PATIENT'S MOUTH. ON (B)(6) 2020, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Inflammation; Pain

  MAUDE report 11488063 ↗
• InjuryNov 15, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT 2 WEEKS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #30, IT WAS VERIFIED ITS NON-OSSEOINTEGRATION. THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOADING. THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Pain; Tissue Damage; Unspecified Infection

  MAUDE report 7032246 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT, 7 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #19, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Tissue Damage

  MAUDE report 7020564 ↗
• InjuryNov 9, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT 2 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #30 IT WAS VERIFIED ITS NON-OSSEOINTEGRATION. IMMEDIATE LOAD WAS NOT PERFORMED AND PATIENT PRESENTED BONE TYPE II.

  Patient problems: Tissue Damage

  MAUDE report 7013121 ↗