Neodent 109.592Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07898237568447), received between Dec 14, 2017 and Jan 8, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN FDI 44. ON (B)(6) 2023, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. 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 18471646 ↗
• InjuryAug 14, 2023Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN THE PATIENT'S MOUTH. ON (B)(6) 2023, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH INADEQUATE BONE QUALITY/QUANTITY. 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 17545956 ↗
• InjuryMar 30, 2022Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN THE PATIENT'S MOUTH. ON (B)(6) 2021, 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 13952986 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN FDI 41, FAILURE OCCURRED UPON INSERTION. 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 13210083 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN FDI 25, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. PATIENT PRESENTED WITH INADEQUATE BONE QUALITY/QUANTITY. 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 11438745 ↗
• InjuryMar 4, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 27. ON (B)(6) 2020, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND INADEQUATE BONE QUALITY/QUANTITY. 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 11416118 ↗
• InjuryJan 13, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 33. ON (B)(6) 2020, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. 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 11161815 ↗
• InjuryNov 16, 2020Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN THE PATIENT'S MOUTH. ON (B)(6) 2020, 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 10846624 ↗
• 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 9991904 ↗
• InjuryNov 6, 2019Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 15#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 20N.CM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE II, BONE GRAFT WAS PLACED AND IMMEDIATE IMPLANT WAS PERFORMED.

  Patient problems: Pain; Tissue Damage; Unspecified Infection

  MAUDE report 9286838 ↗
• InjuryOct 23, 2019Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 15 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE II BONE. THE SITE WAS GRAFTED. THE CLINICIAN REPORTED THE PATIENT'S PERI-IMPLANTITIS, PAIN, SWELLING AND INADEQUATE HEALING. THE IMPLANT WAS TORQUED TO 20 NCM. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9226394 ↗
• 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 8953693 ↗
• InjuryDec 14, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT, 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #20; ITS NON-OSSEOINTEGRATION WAS OBSERVED. A 10 NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Fistula; Pain; Tissue Damage

  MAUDE report 7116314 ↗