Neodent 109.522Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07898237567761), received between Nov 10, 2017 and Mar 31, 2022 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN FDI 15. 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 13968724 ↗
• InjuryMar 24, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 16. 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 13894145 ↗
• InjuryMar 14, 2022Failure to Osseointegrate; Failure to Osseointegrate

  THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN ADA 15. ON (B)(6) 2021, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

  MAUDE report 13763137 ↗
• InjuryNov 18, 2019Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) ¿ THE DENTIST REPORTED THAT 20 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Damage; Unspecified Infection

  MAUDE report 9334389 ↗
• InjuryApr 5, 2018Failure to Osseointegrate; Failure to Osseointegrate

  RP 011085 - THE DENTIST REPORTED THAT 8 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 10#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED BONE TYPE IV, 40NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS PERFORMED.

  Patient problems: Pain; Tissue Damage

  MAUDE report 7400251 ↗
• InjuryNov 14, 2017Loss of Osseointegration; Loss of Osseointegration

  THE CLINICIAN REPORTED THAT 5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED, IN ADA SITE #14 OF THE PATIENT'S MOUTH LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH TYPE II BONE. HYGIENE AROUND THE IMPLANT WAS FAIR. THE PRODUCT WILL BE RETURNED FOR INVESTIGATION. NO OPERATIVE OR POST-OPERATIVE COMPLICATIONS WERE REPORTED FOR THE PATIENT.

  Patient problems: Tissue Damage

  MAUDE report 7030147 ↗
• InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

  (B)(4) - THE DENTIST REPORTED THAT, 1 WEEK AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #13, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE 40 NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE II.

  Patient problems: Fistula; Tissue Damage; Unspecified Infection

  MAUDE report 7020319 ↗