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Neodent 109.775Recalls & reported problems

JJGC Indústria e Comércio de Materiais Dentários S/A. · TITAMAX SMART EX IMPLANT · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07898237569833), received between Nov 10, 2017 and Aug 22, 2019 — classified as 3 injuries.

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

Most reported problems

Device problems

  • Failure to Osseointegrate2
  • Loss of Osseointegration1

Patient problems

  • Tissue Damage3
  • Unspecified Infection1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 22, 2019Loss of Osseointegration; Loss of Osseointegration

    (B)(4)- THE DENTIST REPORTED THAT 3 YEARS AND 10 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 25N.CM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE II.

    Patient problems: Tissue Damage

    MAUDE report 8921875 ↗
  • InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

    (B)(4). THE DENTIST REPORTED THAT, 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #8, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD AND THE PATIENT PRESENTED BONE TYPE III.

    Patient problems: Tissue Damage; Unspecified Infection

    MAUDE report 7021338 ↗
  • InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate

    (B)(4) - THE DENTIST REPORTED THAT ALMOST 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, IT WAS VERIFIED ITS NON-OSSEOINTEGRATION. PATIENT PRESENTED BONE TYPE III AND IMMEDIATE LOAD WAS NOT PERFORMED.

    Patient problems: Tissue Damage

    MAUDE report 7017794 ↗

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

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Sources and updates

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