Neodent 109.781Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07898237569895), received between Nov 9, 2017 and Oct 7, 2019 — 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.

• InjuryOct 7, 2019Fracture; Fracture

  (B)(4)- THE DENTIST REPORTED THAT 7 MONTHS AND 9 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 30#, ITS FRACTURE WAS OBSERVED.

  Patient problems: Failure of Implant; Pain; Tissue Damage

  MAUDE report 9161678 ↗
• InjuryFeb 2, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD.

  Patient problems: Pain; Swelling; Tissue Damage

  MAUDE report 7237289 ↗
• InjuryFeb 2, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). - THE DENTIST REPORTED THAT 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD.

  Patient problems: Pain; Swelling; Tissue Damage

  MAUDE report 7237267 ↗
• InjuryFeb 1, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). - THE DENTIST REPORTED THAT 2 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #30, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD.

  Patient problems: Tissue Damage

  MAUDE report 7235235 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT, ABOUT 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #13, ITS NON-OSSEOINTEGRATION WAS OBSERVED. A 35 NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE III.

  Patient problems: Tissue Damage

  MAUDE report 7020074 ↗
• InjuryNov 9, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAO0RAL REGION #29 IT WAS VERIFIED ITS NON-OSSEOINTEGRATION. IMMEDIATE LOAD WAS NOT PERFORMED AND THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7012955 ↗