Neodent 109.325Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07898237567105), received between Nov 9, 2017 and Dec 5, 2025 — classified as 20 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (15 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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2025Fracture; Fracture

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED IN FDI 16. ON (B)(6) 2025, FRACTURE OF THE IMPLANT WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: FISTULA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fistula

  MAUDE report 23732278 ↗
• InjuryJan 27, 2022Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN THE PATIENT'S MOUTH. ON (B)(6) 2021, LOSS OF 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 13368673 ↗
• InjuryJan 13, 2022Failure 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: PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 13254086 ↗
• InjuryJan 13, 2022Failure 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: PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 13254072 ↗
• InjuryJan 13, 2022Failure 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: PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 13254070 ↗
• InjurySep 9, 2020Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2020 IN FDI 36. ON (B)(6) 2020, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain; Swelling; Swelling/ Edema

  MAUDE report 10509593 ↗
• InjuryAug 20, 2020Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 11. 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: INFECTION AND PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10432637 ↗
• InjuryFeb 17, 2020Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 30N.CM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE II AND IMMEDIATE IMPLANT WAS PERFORMED.

  Patient problems: Tissue Damage

  MAUDE report 9716689 ↗
• InjuryFeb 11, 2020Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT 21 DAYS THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED.

  Patient problems: Tissue Damage

  MAUDE report 9695551 ↗
• InjuryOct 28, 2019Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED.

  Patient problems: Tissue Damage

  MAUDE report 9247205 ↗
• InjuryApr 8, 2019Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Tissue Damage

  MAUDE report 8490867 ↗
• InjuryJan 4, 2019Loss of Osseointegration; Loss of Osseointegration

  (B)(4) ¿ THE DENTIST REPORTED THAT 6 YEARS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED BONE TYPE III.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 8218829 ↗
• InjuryOct 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) ¿ THE DENTIST REPORTED THAT 9 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 15#, IT HAD TO BE REMOVED BECAUSE OF SINUS INFECTION. IN ADDITION, 50 NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE IV AND BONE GRAFT WAS EXECUTED.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7923457 ↗
• InjuryAug 29, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Tissue Damage

  MAUDE report 7829901 ↗
• InjuryNov 15, 2017Loss of Osseointegration; Loss of Osseointegration

  (B)(4). THE DENTIST REPORTED THAT, 6 YEARS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #19, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. 60 NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7035325 ↗
• InjuryNov 14, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT, 7 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #11; ITS NON-OSSEOINTEGRATION WAS OBSERVED. FORTY-THREE NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE II) AND BONE GRAFT WAS EXECUTED.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7030862 ↗
• InjuryNov 14, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THE LOSS OF THE DENTAL IMPLANT, BUT DID NOT PROVIDE INFORMATION ABOUT THE CASE.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 7030470 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT, AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Tissue Damage

  MAUDE report 7022235 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT, AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Tissue Damage

  MAUDE report 7021033 ↗
• InjuryNov 9, 2017Failure to Osseointegrate; Failure to Osseointegrate

  OS 111523 - THE DENTIST REPORTED THE NON-OSSEOINTEGRATION OF A DENTAL IMPLANT INSTALLED IN INTRAORAL REGION #3, AFTER PROSTHESIS INSTALLATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Tissue Damage

  MAUDE report 7012592 ↗