Neodent 109.897Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07899878001058), received between Nov 15, 2017 and Nov 15, 2017 — classified as 6 injuries.

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

• InjuryNov 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). THE DENTIST REPORTED THAT, THE DENTAL IMPLANT WAS REMOVED DURING ITS INSTALLATION SURGERY BECAUSE NO PRIMARY STABILITY WAS ACHIEVED. THERE IS NO INFORMATION ABOUT IMPLANT REPLACEMENT IN THE SAME SURGICAL ACT.

  Patient problems: Tissue Damage

  MAUDE report 7035236 ↗
• InjuryNov 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) - THE DENTIST REPORTED THAT, THE DENTAL IMPLANT WAS REMOVED DURING ITS INSTALLATION SURGERY BECAUSE NO PRIMARY STABILITY WAS ACHIEVED. THERE IS NO INFORMATION ABOUT IMPLANT REPLACEMENT IN THE SAME SURGICAL ACT.

  Patient problems: Tissue Damage

  MAUDE report 7035221 ↗
• InjuryNov 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). THE DENTIST REPORTED THAT, THE DENTAL IMPLANT WAS REMOVED DURING ITS INSTALLATION SURGERY BECAUSE NO PRIMARY STABILITY WAS ACHIEVED. THERE IS NO INFORMATION ABOUT IMPLANT REPLACEMENT IN THE SAME SURGICAL ACT.

  Patient problems: Tissue Damage

  MAUDE report 7035200 ↗
• InjuryNov 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). THE DENTIST REPORTED THAT, THE DENTAL IMPLANT WAS REMOVED DURING ITS INSTALLATION SURGERY BECAUSE NO PRIMARY STABILITY WAS ACHIEVED. THERE IS NO INFORMATION ABOUT IMPLANT REPLACEMENT IN THE SAME SURGICAL ACT.

  Patient problems: Tissue Damage

  MAUDE report 7035198 ↗
• InjuryNov 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). THE DENTIST REPORTED THAT, THE DENTAL IMPLANT WAS REMOVED DURING ITS INSTALLATION SURGERY BECAUSE NO PRIMARY STABILITY WAS ACHIEVED. THERE IS NO INFORMATION ABOUT IMPLANT REPLACEMENT IN THE SAME SURGICAL ACT. THE IMPLANT WAS BEING INSTALLED IN INTRAORAL REGION #13.

  Patient problems: Tissue Damage

  MAUDE report 7035150 ↗
• InjuryNov 15, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT, 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #20; ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7033030 ↗