Neodent 109.896Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07899878001041), received between Nov 15, 2017 and Jul 1, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2024Fracture; Fracture

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2016 IN ADA 29. ON (B)(6) 2024, FRACTURE OF THE IMPLANT 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 19649609 ↗
• InjuryJul 1, 2024Fracture; Fracture

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2016 IN ADA 29. ON (B)(6) 2024, FRACTURE OF THE IMPLANT 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 19646237 ↗
• InjuryDec 30, 2022Fracture; Fracture

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2016 IN ADA 29. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE AND RIDGE AUGMENTATION. ON (B)(6) 2022, FRACTURE OF THE IMPLANT WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY AND INCREASED SENSITIVITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fibrosis; Hyperresponsive to stimuli; Unspecified Infection

  MAUDE report 16079224 ↗
• InjuryDec 30, 2022Fracture; Fracture

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2016 IN ADA 29. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE AND RIDGE AUGMENTATION. ON (B)(6) 2022, FRACTURE OF THE IMPLANT WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY AND INCREASED SENSITIVITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fibrosis; Hyperresponsive to stimuli; Unspecified Infection

  MAUDE report 16078511 ↗
• 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. THERE IS NO INFORMATION ABOUT IMPLANT REPLACEMENT IN THE SAME SURGICAL ACT.

  Patient problems: Tissue Damage

  MAUDE report 7036543 ↗
• InjuryNov 15, 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. THERE IS NO INFORMATION ABOUT IMPLANT REPLACEMENT IN THE SAME SURGICAL ACT.

  Patient problems: Tissue Damage

  MAUDE report 7035165 ↗
• InjuryNov 15, 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. THERE IS NO INFORMATION ABOUT IMPLANT REPLACEMENT IN THE SAME SURGICAL ACT.

  Patient problems: Tissue Damage

  MAUDE report 7035160 ↗
• InjuryNov 15, 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. THERE IS NO INFORMATION ABOUT IMPLANT REPLACEMENT IN THE SAME SURGICAL ACT.

  Patient problems: Tissue Damage

  MAUDE report 7035153 ↗