Neodent 109.586Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07898237568386), received between Nov 10, 2017 and Jun 17, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2025Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN THE PATIENT'S MOUTH. ON (B)(6) 2025, 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 22247410 ↗
• InjuryJan 13, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 44. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. 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 11161706 ↗
• InjuryOct 29, 2020Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 N FDI 45. 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: PAIN, SWELLING AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Swelling/ Edema

  MAUDE report 10757832 ↗
• InjuryOct 29, 2020Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Swelling/ Edema

  MAUDE report 10757821 ↗
• InjuryAug 3, 2020Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 23. ON (B)(6) 2020, NON-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; Tissue Damage

  MAUDE report 10357979 ↗
• InjurySep 2, 2019Loss of Osseointegration; Loss of Osseointegration

  (B)(4) - THE DENTIST REPORTED THAT 1 YEAR AND 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 60N.CM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 8953662 ↗
• InjurySep 2, 2019Adverse 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 BECAUSE IT DID NOT ACHIEVE A GOOD PRIMARY STABILITY. MOREOVER, THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Tissue Damage

  MAUDE report 8953551 ↗
• InjurySep 3, 2018Loss of Osseointegration; Loss of Osseointegration

  (B)(4) ¿ THE DENTIST REPORTED THAT AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 6#, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED PERI-IMPLANTITIS.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7840969 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT, 2 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #15 ITS NON-OSSEOINTEGRATION WAS OBSERVED. THIRTY NCM OF PRIMARY STABILITY WAS ACHIEVED. THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/ QUANTITY (BONE TYPE IV).

  Patient problems: Tissue Damage

  MAUDE report 7020719 ↗