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Neodent 140.585Recalls & reported problems

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

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

Adverse event reports
5
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07899878016373), received between Nov 9, 2017 and Aug 15, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (5 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 Osseointegrate5

Patient problems

  • Tissue Damage4
  • Unspecified Infection3
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 15, 2022Failure to Osseointegrate; Failure to Osseointegrate

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 13. ON (B)(6) 2020, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV. 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 15228107 ↗
  • InjuryJun 29, 2018Failure to Osseointegrate; Failure to Osseointegrate

    (B)(4) ¿ THE DENTIST REPORTED THAT 1 YEAR AND 2 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED BONE TYPE II.

    Patient problems: Tissue Damage; Unspecified Infection

    MAUDE report 7651289 ↗
  • InjuryJun 28, 2018Failure to Osseointegrate; Failure to Osseointegrate

    (B)(4) ¿ THE DENTIST REPORTED THAT 6 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED BONE TYPE III.

    Patient problems: Tissue Damage; Unspecified Infection

    MAUDE report 7648197 ↗
  • InjuryJun 28, 2018Failure to Osseointegrate; Failure to Osseointegrate

    (B)(4). THE DENTIST REPORTED THAT 4 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED BONE TYPE III.

    Patient problems: Tissue Damage; Unspecified Infection

    MAUDE report 7647643 ↗
  • InjuryNov 9, 2017Failure to Osseointegrate; Failure to Osseointegrate

    (B)(4) - THE DENTIST REPORTED THAT ALMOST 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #25 IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. 35 N.CM. OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED. THE PATIENT PRESENTED BONE TYPE II.

    Patient problems: Tissue Damage

    MAUDE report 7015917 ↗

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Sources and updates

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