Neodent 109.161Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07898237566757), received between Nov 9, 2017 and Nov 10, 2017 — classified as 4 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (3 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.

• InjuryNov 10, 2017Loss of Osseointegration; Loss of Osseointegration

  (B)(4) - THE DENTIST REPORTED THAT, 1 YEAR AND 5 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #14, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD AND THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Swelling; Tissue Damage

  MAUDE report 7021349 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT 2 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #21, IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOADING AND THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Pain; Tissue Damage; Unspecified Infection

  MAUDE report 7018895 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT 6 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, IT WAS VERIFIED ITS NON-OSSEOINTEGRATION. THE PATIENT PRESENTED BONE TYPE III AND IMMEDIATE LOAD WAS NOT PERFORMED.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7018021 ↗
• InjuryNov 9, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT 5 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #18, IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. A 32 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED. THE PATIENT PRESENTED BONE TYPE II AND BONE GRAFT WAS EXECUTED.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7012935 ↗