Neodent 140.669Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07899878016816), received between Nov 14, 2017 and Oct 17, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2024Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN THE PATIENT'S MOUTH. ON (B)(6) 2024, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 20474474 ↗
• InjuryFeb 17, 2023Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN FDI 33. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. 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 16401268 ↗
• InjuryDec 2, 2022Fracture; Fracture

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN ADA 4. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2022, FRACTURE OF THE IMPLANT WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III, FAIR ORAL HYGIENE AND INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY, BLEEDING, HYPERSENSITIVITY AND NUMBNESS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Numbness

  MAUDE report 15907909 ↗
• InjuryDec 2, 2022Fracture; Fracture

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN ADA 4. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2022, FRACTURE OF THE IMPLANT WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III, FAIR ORAL HYGIENE AND INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY, BLEEDING, HYPERSENSITIVITY AND NUMBNESS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Numbness

  MAUDE report 15907611 ↗
• InjuryMar 26, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 21. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2021, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. 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 11577263 ↗
• InjuryJan 11, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 26. DETAILS OF SURGERY: SINUS AUGMENTATION AND IMMEDIATE EXTRACTION SITE. ON (B)(6) 2020, NON-OSSEOINTEGRATION WAS VERIFIED. 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 11149799 ↗
• InjuryAug 10, 2020Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN THE PATIENT'S MOUTH. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2020, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 10387062 ↗
• InjuryJan 16, 2020Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT 6 MONTHS AND 6 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION ADA 9, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 32N.CM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE III.

  Patient problems: Pain; Tissue Damage

  MAUDE report 9597750 ↗
• InjuryNov 14, 2017Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT ALMOST FIVE MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN ADA SITE #13 OF THE PATIENT¿S MOUTH, NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED TYPE II BONE. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. PATIENT REPORTED PAIN, MOBILITY AND ABSCESS AT TIME OF EVENT, NO FURTHER COMPLICATIONS WERE OBSERVED.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7029699 ↗
• InjuryNov 14, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT, 1.5 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #7, ITS NON-OSSEOINTEGRATION WAS OBSERVED. FIFTY NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS IMMEDIATELY LOADED. THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Tissue Damage

  MAUDE report 7029559 ↗