Neodent 109.1007Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07899878023470), received between Jan 3, 2018 and Sep 23, 2022 — classified as 12 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2022Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 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 15474428 ↗
• InjurySep 23, 2022Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 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 15471621 ↗
• InjuryAug 29, 2022Separation Failure; Separation Failure

  THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN THE PATIENT'S MOUTH, 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 15314763 ↗
• InjuryAug 29, 2022Separation Failure; Separation Failure

  THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN THE PATIENT'S MOUTH, 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 15313137 ↗
• InjuryMar 4, 2022Adverse 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 ADA 10, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. 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 13670285 ↗
• InjuryMar 4, 2022Adverse 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 ADA 10, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. 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 13669422 ↗
• InjuryFeb 14, 2020Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4)¿ THE DENTIST REPORTED THAT 2 MONTHS AND 18 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED BONE TYPE III.

  Patient problems: Inflammation; Tissue Damage

  MAUDE report 9712836 ↗
• InjuryFeb 4, 2020Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN THE PATIENT'S MOUTH. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Inflammation

  MAUDE report 9668368 ↗
• InjuryFeb 26, 2019Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT OVER 4 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN THE MOUTH, THE IMPLANT DID NOT OSSEOINTEGRATE IN TYPE III BONE. CLINICIAN REPORTS THE PATIENT'S INFECTION, ABSCESS, INSUFFICIENT BONE QUALITY/QUALITY AND GOOD HYGIENE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST- OPERATIVE COMPLICATIONS. RP.017755.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 8372104 ↗
• InjuryAug 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE DAY THE IMMEDIATE IMPLANT WAS PLACED IN ADA SITE 25 IN THE MOUTH, PRIMARY STABILITY WAS NOT ACHIEVED IN TYPE III BONE. CLINICIAN REPORTS INSUFFICIENT BONE QUANTITY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7822314 ↗
• InjuryJan 3, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT 5 MONTHS AFTER THE DENTAL IMPLANT IN ADA SITE 14 WAS PLACED, THE IMPLANT LOST OSSEOINTEGRATION IN TYPE III BONE. CLINICIAN REPORTS INSUFFICIENT BONE QUANTITY/QUALITY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7162144 ↗
• InjuryJan 3, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT NEARLY 2 MONTHS AFTER THE DENTAL IMPLANT IN ADA SITE 13 WAS PLACED, THE IMPLANT FAILED TO OSSEOINTEGRATE IN TYPE III BONE. CLINICIAN NOTED SURROUNDING GRANULATED TISSUE, A LOCAL INFECTION AND BONE LOSS. A BONE GRAFT WAS COMPLETED AFTER THE IMPLANT REMOVAL. 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 7162142 ↗