Neodent 109.807Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · TITAMAX SMART IMPLANT · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07899878000167), received between Jul 16, 2019 and Jan 23, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (2 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.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Tissue Damage1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 23, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6)2017 IN THE PATIENT'S MOUTH. ON (B)(6)2025, 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 24166819 ↗InjuryJul 16, 2019Loss of Osseointegration; Loss of Osseointegration
(B)(4) - THE DENTIST REPORTED THAT, 5 YEARS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #24, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED BONE TYPE III.
Patient problems: Tissue Damage; Unspecified Infection
MAUDE report 8795055 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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