Neodent 109.774Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07898237569826), received between Nov 9, 2017 and Feb 15, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

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

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN THE PATIENT'S MOUTH. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 11329592 ↗
• InjuryApr 23, 2020Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT 3 MONTHS AND 6 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 23#, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE II).

  Patient problems: Pain; Tissue Damage; Unspecified Infection

  MAUDE report 9990674 ↗
• InjuryJun 12, 2019Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT 2 MONTHS AND 6 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED BONE TYPE III.

  Patient problems: Tissue Damage

  MAUDE report 8693354 ↗
• InjuryNov 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). THE DENTIST REPORTED THAT, IT WAS NECESSARY TO REMOVE THE DENTAL IMPLANT DURING ITS INSTALLATION SURGERY IN CONSEQUENCE OF THE PATIENT¿S BONE PLATE FRACTURE.

  Patient problems: Tissue Damage

  MAUDE report 7030281 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE IMPLANT WAS REMOVED DUE TO FRACTURE OF THE BUCCAL BONE PLATE. THE IMPLANT WAS NOT REPLACED AT THE SAME EVENT AND BONE GRAFT WAS EXECUTED.

  Patient problems: Tissue Damage

  MAUDE report 7020047 ↗
• InjuryNov 9, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT'S MOUTH IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. A 35 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED. THE PATIENT PRESENTED BONE TYPE III.

  Patient problems: Fistula; Tissue Damage; Unspecified Infection

  MAUDE report 7012989 ↗