Neodent 109.670Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07898237569178), received between Nov 10, 2017 and Jun 23, 2023 — classified as 14 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2023Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Fibrosis; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 17194597 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN FDI 14. ON (B)(6) 2023, THE IMPLANT WAS REMOVED UPON CLINICIAN¿S DECISION. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16891718 ↗
• InjuryMay 20, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN FDI 14. DETAILS OF SURGERY: SINUS AUGMENTATION. ON 2022-02-15, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fibrosis; Pain

  MAUDE report 14463954 ↗
• InjuryMar 21, 2022Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN THE PATIENT'S MOUTH. ON (B)(6) 2021, 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 13843480 ↗
• InjuryDec 27, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 15. ON (B)(6) 2021, 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 13089449 ↗
• InjuryDec 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN FDI 45, FAILURE OCCURRED UPON INSERTION. 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 13089356 ↗
• InjuryDec 10, 2019Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4)¿ THE DENTIST REPORTED THAT 3 MONTHS AND 13 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 25N.CM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE II, BONE GRAFT WAS PLACED AND IMMEDIATE IMPLANT WAS PERFORMED.

  Patient problems: Fistula; Pain; Tissue Damage

  MAUDE report 9446582 ↗
• InjuryNov 19, 2019Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  (B)(4): THE DENTIST REPORTED THAT 1 YEAR AND 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 20#, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED BONE TYPE III.

  Patient problems: Pain; Tissue Damage; Unspecified Infection

  MAUDE report 9341099 ↗
• InjurySep 18, 2019Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT ALMOST 1.5 YEARS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 20 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE III BONE. THE CLINICIAN REPORTED AN INFECTION, PAIN, IMPLANT MOBILITY AND BLEEDING IN THIS PATIENT WITH GOOD ORAL HYGIENE. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 9083676 ↗
• InjuryAug 29, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS 2.5 MONTHS AFTER THE DENTAL IMPLANT AND DENTURE WERE PLACED IN ADA SITE 13 IN THE MOUTH, THE IMPLANT HAD NOT ACHIEVED INTEGRATION IN TYPE III BONE. CLINICIAN REPORTS DEHISCENCE, FENESTRATION AND MOBILITY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7830382 ↗
• InjuryAug 29, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS 2.5 MONTHS AFTER THE DENTAL IMPLANT AND DENTURE WERE PLACED IN ADA SITE 4 IN THE MOUTH, THE IMPLANT HAD NOT ACHIEVED INTEGRATION IN TYPE III BONE. CLINICIAN REPORTS DEHISCENCE, FENESTRATION AND MOBILITY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7830369 ↗
• InjuryAug 29, 2018Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  THE CLINICIAN REPORTS 9 MONTHS AFTER THE DENTAL IMPLANT AND DENTURE WERE PLACED IN ADA SITE 4 IN THE MOUTH, THE IMPLANT HAD NOT ACHIEVED INTEGRATION IN TYPE III BONE. CLINICIAN REPORTS AN INFECTION AND DEHISCENCE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

  Patient problems: Pain; Tissue Damage; Unspecified Infection

  MAUDE report 7830363 ↗
• InjuryAug 29, 2018Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  THE CLINICIAN REPORTS 9 MONTHS AFTER THE DENTAL IMPLANT AND DENTURE WERE PLACED IN ADA SITE 20 IN THE MOUTH, THE IMPLANT HAD NOT ACHIEVED INTEGRATION IN TYPE III BONE. CLINICIAN REPORTS AN INFECTION AND DEHISCENCE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

  Patient problems: Pain; Tissue Damage; Unspecified Infection

  MAUDE report 7830355 ↗
• InjuryNov 10, 2017Loss of Osseointegration; Loss of Osseointegration

  (B)(4) - THE DENTIST REPORTED THAT, 1 YEAR AND 5 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #6, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE III.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7020767 ↗