Neodent 109.140Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07898237566658), received between Nov 8, 2017 and Feb 6, 2025 — classified as 19 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (12 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.

• InjuryFeb 6, 2025Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2013 IN FDI 25. ON (B)(6) 2024 , LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fibrosis

  MAUDE report 21326306 ↗
• InjuryNov 8, 2019Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT 1 MONTH AND 11 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 7#, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, IMMEDIATE LOAD PROCEDURE WAS DONE.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 9296741 ↗
• InjuryNov 8, 2019Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT ALMOST 2 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 10#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED BONE TYPE I, IMMEDIATE IMPLANT WAS PERFORMED AND IMMEDIATE LOAD PROCEDURE WAS DONE.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 9296626 ↗
• InjuryNov 8, 2019Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT 5 MONTHS AND 14 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 7#, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, IMMEDIATE LOAD PROCEDURE WAS DONE.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 9296621 ↗
• InjuryMar 21, 2019Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 23#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 30N.CM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE II AND BONE GRAFT WAS PLACED.

  Patient problems: Tissue Damage

  MAUDE report 8441481 ↗
• InjuryMay 10, 2018Loss of Osseointegration; Loss of Osseointegration

  (B)(4) - THE DENTIST REPORTED THAT AFTER 3 YEARS AND 1 MONTH DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 24#, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 50 NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE II AND TRAUMA OVER THE IMPLANT HAS HAPPENED.

  Patient problems: Tissue Damage

  MAUDE report 7504217 ↗
• InjuryMay 10, 2018Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT AFTER 1 YEAR AND 3 MONTHS DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 25#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 30 NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE III.

  Patient problems: Tissue Damage

  MAUDE report 7504212 ↗
• InjuryMay 3, 2018Loss of Osseointegration; Loss of Osseointegration

  (B)(4) - THE DENTIST REPORTED THAT AFTER 4 YEARS AND 6 MONTHS DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 8#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED BONE TYPE IV.

  Patient problems: Swelling; Tissue Damage; Unspecified Infection

  MAUDE report 7483184 ↗
• InjuryMay 3, 2018Fracture; Fracture

  (B)(4) - THE DENTIST REPORTED THAT AFTER 5 YEARS AND 8 MONTHS DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 8#, HE HAD TO REMOVE IT BECAUSE OF ITS FRACTURE. IN ADDITION, THE PATIENT PRESENTED BONE TYPE IV AND BONE GRAFT WAS EXECUTED.

  Patient problems: Pain; Swelling; Tissue Damage

  MAUDE report 7483181 ↗
• InjuryMay 3, 2018Loss of Osseointegration; Loss of Osseointegration

  RP 011728 - THE DENTIST REPORTED THAT AFTER 4 YEARS AND 6 MONTHS DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 9#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED BONE TYPE IV.

  Patient problems: Pain; Swelling; Tissue Damage

  MAUDE report 7483174 ↗
• InjuryNov 15, 2017Loss of Osseointegration; Loss of Osseointegration

  (B)(4) - THE DENTIST REPORTED THE LOSS OF OSSEOINTEGRATION OF A DENTAL IMPLANT, BUT DID NOT PROVIDE INFORMATION ABOUT HOW LONG THE IMPLANT REMAINED INSTALLED.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7032208 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT, 6 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #19, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE 45 NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS IMMEDIATELY LOADED. THE PATIENT PRESENTED BONE TYPE III.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7020380 ↗
• InjuryNov 10, 2017Loss of Osseointegration; Loss of Osseointegration

  "(B)(4) - THE DENTIST REPORTED THAT 2 YEARS AND 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #3, AND 1 YEAR AND 8 MONTHS AFTER PROSTHESIS INSTALLATION, IT WAS VERIFIED ITS LOSS OF OSSEOINTEGRATION. NO FURTHER INFORMATION WAS PROVIDED."

  Patient problems: Tissue Damage

  MAUDE report 7017493 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT 1 YEAR AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT'S MOUTH, IT WAS VERIFIED ITS NON-OSSEOINTEGRATION. TWENTY NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7017360 ↗
• InjuryNov 9, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #25, IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. TWENTY NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED. THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Tissue Damage

  MAUDE report 7016020 ↗
• InjuryNov 9, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT 6 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #10 IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. TWENTY NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT EXECUTED. THE PATIENT PRESENTED BONE TYPE III.

  Patient problems: Tissue Damage

  MAUDE report 7015850 ↗
• InjuryNov 9, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #24, IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. A 45 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT EXECUTED. PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE III).

  Patient problems: Tissue Damage

  MAUDE report 7012623 ↗
• InjuryNov 8, 2017Failure to Osseointegrate; Failure to Osseointegrate

  OS 110949 - THE DENTIST REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #24 IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. SIXTY-FIVE NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT EXECUTED. PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE III).

  Patient problems: Tissue Damage

  MAUDE report 7009156 ↗
• InjuryNov 8, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4). THE DENTIST REPORTED THE DENTAL IMPLANT NON-OSSEOINTEGRATION. PATIENT PRESENTED BONE TYPE III AND HAD INFECTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Tissue Damage; Unspecified Infection

  MAUDE report 7009138 ↗