Neodent 109.1008Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07899878023487), received between Dec 21, 2017 and Jan 23, 2023 — classified as 11 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2023Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN ADA 29. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16228835 ↗
• InjuryJan 23, 2023Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN ADA 29. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16225818 ↗
• InjuryDec 4, 2020Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN ADA 20. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10944128 ↗
• InjuryDec 4, 2020Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN ADA 20. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10943449 ↗
• InjuryOct 4, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT ALMOST 6 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. CLINICIAN NOTED PATIENT'S PAIN. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

  Patient problems: Failure of Implant; Pain; Tissue Damage

  MAUDE report 7933810 ↗
• InjurySep 13, 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 13 IN THE MOUTH, PRIMARY STABILITY WAS NOT ACHIEVED IN TYPE III BONE. THE IMPLANT WAS REMOVED DUE TO INSUFFICIENT BONE QUALITY/QUANTITY AND THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7874880 ↗
• InjurySep 5, 2018Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  THE CLINICIAN REPORTS THAT MORE THAN SIX MONTHS AFTER THE DENTAL IMPLANT AND BRIDGE WERE PLACED IN ADA SITE 4 IN THE MOUTH, THE IMPLANT LOST NTEGRATION IN TYPE II BONE. CLINICIAN REPORTS TRAUMA, PAIN AND MOBILITY. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7848592 ↗
• InjuryJul 2, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT 5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 20 IN THE MOUTH, THE IMPLANT HAD NOT ACHIEVED OSSEOINTEGRATION. NO INFECTION WAS REPORTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS. (B)(4).

  Patient problems: Tissue Damage

  MAUDE report 7656088 ↗
• InjuryJul 2, 2018Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem; Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem

  THE CLINICIAN REPORTED THAT ON THE DAY THE IMPLANT WAS PLACED IN ADA SITE 26 IN THE MOUTH, THERE WAS NO PRIMARY STABILITY. CLINICIAN REPORTS PAIN. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS. (B)(4).

  Patient problems: Pain; Tissue Damage

  MAUDE report 7656059 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER THE IMMEDIATE EXTRACTION OF THE TOOTH IN ADA SITE 19, THE CLINICIAN REPORTS THE IMPLANT FAILED UPON INSERTION DUE TO INADEQUATE PRIMARY STABILITY. A BONE GRAFT WAS COMPLETED. INSUFFICIENT BONE QUALITY AND FENESTRATION WERE NOTED. THE IMPLANT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7162151 ↗
• InjuryDec 21, 2017Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTED THAT NEARLY 8 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 4, LOSS OF OSSEOINTEGRATION WAS NOTED IN TYPE IV BONE. CLINICIAN NOTED FENESTRATION. A BONE GRAFT WAS PERFORMED. AN INFECTION WAS NOT PRESENT. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7137123 ↗