Neodent 109.646Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07898237568942), received between Nov 10, 2017 and Nov 3, 2025 — classified as 19 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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN THE PATIENT'S MOUTH. ON (B)(6) 2025, 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 23457336 ↗
• InjuryDec 30, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN THE PATIENT'S MOUTH. ON 2024(B)(6) 2024, 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 21043169 ↗
• InjurySep 26, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2023 IN THE PATIENT'S MOUTH. ON (B)(6) 2023, 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 20313376 ↗
• InjuryOct 6, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN THE PATIENT'S MOUTH. 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 15553593 ↗
• InjuryMay 27, 2022Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2013 IN THE PATIENT'S MOUTH. ON (B)(6) 2021, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV AND INADEQUATE BONE QUALITY/QUANTITY. 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 14524804 ↗
• InjuryOct 23, 2020Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN FDI 32. ON (B)(6) 2017, 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 10729185 ↗
• InjuryAug 24, 2020Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 36. ON (B)(6) 2020, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 10444437 ↗
• InjurySep 17, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT 11 DAYS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 30#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED INSUFFICIENT QUANTITY/QUALITY (BONE TYPE III), 30 NCM OF PRIMARY STABILITY WAS ACHIEVED AND FENESTRATION OCCURRED DURING SURGERY. THE DENTIST ALSO REPORTED THAT MAYBE THE PATIENT HAS NOT TAKE HIS MEDICINE BECAUSE THERE WERE INFECTION 2 MONTHS AGO.

  Patient problems: Fistula; Tissue Damage; Unspecified Infection

  MAUDE report 7883206 ↗
• InjuryAug 29, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT 2 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 19#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. 30 NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY QUANTITY (BONE TYPE III) AND IMMEDIATE IMPLANT WAS PERFORMED.

  Patient problems: Pain; Tissue Damage; Unspecified Infection

  MAUDE report 7829191 ↗
• InjuryJun 6, 2018Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  THE CLINICIAN REPORTED THAT NEARLY 1 YEAR AND 3 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 23 IN THE MOUTH, THE IMPLANT HAD LOST OSSEOOINTEGRATION. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7574684 ↗
• InjuryMar 16, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT 1 MONTH AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #19, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 45NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE III, THE PROCEDURE OF IMMEDIATE IMPLANT WAS PERFORMED AND BONE GRAFT WAS EXECUTED.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7346919 ↗
• InjuryFeb 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICIAN REPORTED THAT ON THE DAY THE IMPLANT WAS PLACED IN ADA SITE 26, A FAILURE OCCURRED UPON INSERTION IN TYPE II BONE. A BONE GRAFT WAS NOT PLACED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 7290131 ↗
• InjuryNov 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). THE DENTIST REPORTED THAT, THE DENTAL IMPLANT WAS REMOVED DURING ITS INSTALLATION SURGERY BECAUSE NO PRIMARY STABILITY WAS ACHIEVED. THE IMPLANT WAS NOT REPLACED IN THE SAME SURGICAL ACT.

  Patient problems: Tissue Damage

  MAUDE report 7036553 ↗
• InjuryNov 15, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT, ALMOST 7 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #12, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/ QUANTITY (BONE TYPE III).

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7032335 ↗
• InjuryNov 15, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT ALMOST 9 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #4, IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE IV) AND BONE GRAFT WAS EXECUTED.

  Patient problems: Tissue Damage

  MAUDE report 7032209 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT, 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #19, ITS NON-OSSEOINTEGRATION WAS OBSERVED. 45 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 7021995 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT, ALMOST 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #30, ITS NON-OSSEOINTEGRATION WAS OBSERVED. TEN NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE IV AND BONE GRAFT WAS EXECUTED.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7021146 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THE NON-OSSEOINTEGRATION OF A DENTAL IMPLANT AFTER ITS INSTALLATION IN PATIENT¿S MOUTH. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 7019950 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT, 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #29, ITS NON-OSSEOINTEGRATION WAS OBSERVED. FORTY-FIVE NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE III.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7019438 ↗