Neodent 140.739Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07899878017059), received between Oct 22, 2018 and Aug 2, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 2, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN FDI 31. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2021, 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 12262257 ↗
• InjuryApr 6, 2021Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN FDI 31. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2021, 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 11622874 ↗
• InjuryDec 15, 2020Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 31. ON (B)(6) 2020, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Fibrosis; Unspecified Infection

  MAUDE report 11006239 ↗
• InjuryJun 8, 2019Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTED THAT OVER 3 MONTHS AFTER THE IMMEDIATE DENTAL IMPLANT WAS PLACED IN ADA SITE 23 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE II BONE. THE IMPLANT WAS LOST AT THE TIME OF THE FINAL IMPRESSION. THE CLINICIAN TORQUED THE IMPLANT TO 30 NCM. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: Tissue Damage

  MAUDE report 8681254 ↗
• InjuryOct 22, 2018Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration

  THE CLINICIAN REPORTED THAT OVER 2 YEARS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 25 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE II BONE. CLINICIAN NOTED THE IMPLANT WAS LOST WHEN THE HEALING ABUTMENT WAS REMOVED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: Failure of Implant; Tissue Damage

  MAUDE report 7993099 ↗