Neodent 109.999Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07899878023388), received between Dec 15, 2017 and Sep 19, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 19, 2018Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTED THAT NEARLY 1.5 YEARS AFTER THE DENTAL IMPLANT AND TEMPORARY MULTI-UNIT ABUTMENTS WERE PLACED IN ADA SITE 13 IN THE MOUTH, THE IMPLANT LOST OSSEOINTEGRATION. CLINICIAN REPORTS PATIENT HAD A BIOMECHANICAL OVERLOAD. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: Failure of Implant; Tissue Damage

  MAUDE report 7889465 ↗
• InjuryMay 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICIAN REPORTED THAT ON THE DAY THE IMPLANT WAS PLACED IN ADA SITE #14 IN THE MOUTH, A FAILURE OCCURRED UPON INSERTION. ANOTHER IMPLANT WAS NOT PLACED IN THE SAME SITE ON THE SAME DAY. CLINICIAN REPORTS NO PRIMARY STABILITY. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS. (B)(4).

  Patient problems: Tissue Damage

  MAUDE report 7502603 ↗
• InjuryDec 15, 2017Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  THE CLINICIAN REPORTED THAT FIVE MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN INTRAORAL SITE #6 OF THE PATIENT¿S MOUTH, NON- OSSEOINTEGRATION WAS OBSERVED. PERI-IMPLANTITIS AND MOBILITY WAS REPORTED. IMMEDIATE LOAD WAS PERFORMED. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST- OPERATIVE PATIENT COMPLICATIONS. (B)(4).

  Patient problems: Tissue Damage

  MAUDE report 7123150 ↗