Neodent 109.523Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07898237567778), received between Nov 10, 2017 and Jan 12, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (14 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6)2015 IN FDI 25. ON (B)(6)2025, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PAIN AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Inflammation; Pain; Unspecified Infection

  MAUDE report 24043842 ↗
• InjuryDec 19, 2022Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 26. ON (B)(6) 2022, LOSS OF 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 16008013 ↗
• InjuryJul 25, 2022Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN FDI 13. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fibrosis

  MAUDE report 15097341 ↗
• InjuryJul 25, 2022Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN FDI 16. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fibrosis

  MAUDE report 15097315 ↗
• InjuryApr 11, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN ADA 15. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2021, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fibrosis

  MAUDE report 14077166 ↗
• InjuryMar 24, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 22. 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 13893984 ↗
• InjuryMar 3, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN THE PATIENT'S MOUTH. 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 13662160 ↗
• InjuryMar 3, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN THE PATIENT'S MOUTH. 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 13662121 ↗
• InjuryMar 15, 2021Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 16. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2021, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN, MOBILITY AND FISTULA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fibrosis; Fistula; Pain

  MAUDE report 11488064 ↗
• InjuryApr 23, 2020Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT 5 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED.

  Patient problems: Pain; Tissue Damage; Unspecified Infection

  MAUDE report 9993090 ↗
• InjuryApr 23, 2020Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4)¿ THE DENTIST REPORTED THAT ALMOST 7 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED.

  Patient problems: Tissue Damage

  MAUDE report 9993015 ↗
• InjuryApr 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) ¿ THE DENTIST REPORTED THAT HAD TO REMOVE THE DENTAL IMPLANT DURING ITS INSTALLATION SURGERY. THERE IS NO FURTHER INFORMATION ABOUT THE CASE.

  Patient problems: Tissue Damage

  MAUDE report 9991996 ↗
• InjuryApr 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4)¿ THE DENTIST REPORTED THAT HAD TO REMOVE THE DENTAL IMPLANT DURING ITS INSTALLATION SURGERY. THERE IS NO FURTHER INFORMATION ABOUT THE CASE.

  Patient problems: Tissue Damage

  MAUDE report 9991794 ↗
• InjuryMar 30, 2020Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT ALMOST 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED.

  Patient problems: Tissue Damage

  MAUDE report 9899368 ↗
• InjuryNov 6, 2018Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT OVER 3 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 14 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. CLINICIAN NOTED PATIENT'S PAIN, MOBILITY AND BRUXISM. 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 8044053 ↗
• InjuryOct 4, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT NEARLY 7 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 7#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED BONE TYPE II AND IMMEDIATE LOAD PROCEDURE WAS PERFORMED.

  Patient problems: Tissue Damage

  MAUDE report 7933803 ↗
• InjuryMay 30, 2018Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTED THAT NEARLY 2 YEARS AFTER THE DENTAL IMPLANT AND FULL UPPER WERE PLACED IN THE MOUTH, THE IMPLANT LOST INTEGRATION IN TYPE I BONE. CLINICIAN REPORTS DEHISCENCE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS. (B)(4).

  Patient problems: Tissue Damage

  MAUDE report 7554528 ↗
• InjuryApr 5, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT 8 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 14#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED BONE TYPE IV, 40NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS PERFORMED.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7400238 ↗
• InjuryFeb 5, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. FORTY (40) NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE IV.

  Patient problems: Pain; Sinus Perforation; Tissue Damage

  MAUDE report 7242171 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT, 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. SIXTY NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS IMMEDIATELY LOADED. THE PATIENT PRESENTED BONE TYPE III.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7021755 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT ALMOST 2 WEEKS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #5, IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. THIRTY-FIVE NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED. THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/ QUANTITY (BONE TYPE IV).

  Patient problems: Tissue Damage

  MAUDE report 7018857 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT 1 MONTH AFTER TWO DENTAL IMPLANTS WERE INSTALLED IN INTRAORAL REGIONS #4 AND #13 IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. FORTY NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS PERFORMED. THE PATIENT PRESENTED BONE TYPE I.

  Patient problems: Tissue Damage

  MAUDE report 7017380 ↗