Neodent 140.754Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · Ti DRIVE ACQUA IMPLANT · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07899878017097), received between Nov 10, 2017 and Jun 17, 2025 — classified as 18 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (11 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
- Failure to Osseointegrate11
- Loss of Osseointegration4
- Difficult to Remove2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Tissue Damage14
- Pain4
- Unspecified Infection3
- Fistula2
- Fibrosis1
- Inflammation1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2014 IN THE PATIENT'S MOUTH. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2025, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN, FISTULA AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fistula; Inflammation; Pain
MAUDE report 22233856 ↗InjuryJan 20, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2015 IN THE PATIENT'S MOUTH. ON (B)(6) 2024, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain
MAUDE report 21192838 ↗InjurySep 21, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2023 IN THE PATIENT'S MOUTH. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2023, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION AND PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain; Unspecified Infection
MAUDE report 17793791 ↗InjuryMay 23, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN FDI 12. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND FISTULA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fistula; Pain
MAUDE report 14473741 ↗InjuryNov 7, 2019Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) ¿ THE DENTIST REPORTED THAT 2 MONTHS AND 11 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 32N.CM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE III.
Patient problems: Tissue Damage
MAUDE report 9291579 ↗InjuryJul 26, 2019Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THAT, 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #10, ITS NON-OSSEOINTEGRATION WAS OBSERVED. 35 NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE II.
Patient problems: Tissue Damage
MAUDE report 8832593 ↗InjuryJul 26, 2019Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THAT, 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #7, ITS NON-OSSEOINTEGRATION WAS OBSERVED. 35 NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE II.
Patient problems: Tissue Damage
MAUDE report 8832592 ↗InjuryJul 3, 2019Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) ¿ THE DENTIST REPORTED THAT AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 45N.CM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE IMPLANT PROCEDURE WAS PERFORMED.
Patient problems: Tissue Damage
MAUDE report 8757330 ↗InjuryAug 29, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) ¿ THE DENTIST REPORTED THAT 3 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 13#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 35NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE II.
Patient problems: Tissue Damage
MAUDE report 7829958 ↗InjuryAug 29, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT 5 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED BONE TYPE III AND 40NCM OF PRIMARY STABILITY WAS ACHIEVED.
Patient problems: Tissue Damage
MAUDE report 7829311 ↗InjuryAug 29, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) ¿ THE DENTIST REPORTED THAT AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Tissue Damage
MAUDE report 7829127 ↗InjuryMay 3, 2018Difficult to Remove; Difficult to Remove
(B)(4) - THE DENTIST REPORTED THAT AFTER 3 MONTHS DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 7#, IT HAD TO BE REMOVED BECAUSE THE DENTIST WAS NOT ABLE TO REMOVE ONLY THE ABUTMENT, WHICH WAS STUCK INTO THE IMPLANT. IN ADDITION, 50NCM OF PRIMARY STABILITY WAS ACHIEVED, IMMEDIATE IMPLANT WAS PERFORMED AND THE PATIENT PRESENTED BONE TYPE II.
Patient problems: Tissue Damage
MAUDE report 7483147 ↗InjuryMay 3, 2018Difficult to Remove; Difficult to Remove
RP 011637- THE DENTIST REPORTED THAT AFTER 3 MONTHS DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 8#, IT HAD TO BE REMOVED BECAUSE THE DENTIST WAS NOT ABLE TO REMOVE ONLY THE ABUTMENT, WHICH WAS STUCK INTO THE IMPLANT. IN ADDITION, 50NCM OF PRIMARY STABILITY WAS ACHIEVED, IMMEDIATE IMPLANT WAS PERFORMED AND THE PATIENT PRESENTED BONE TYPE II.
Patient problems: Tissue Damage
MAUDE report 7483142 ↗InjuryNov 14, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT, 2 MONTHS AND 2 WEEKS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #5, ITS NON- OSSEOINTEGRATION WAS OBSERVED. FIFTEEN NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE IV AND BONE GRAFT WAS EXECUTED.
Patient problems: Tissue Damage; Unspecified Infection
MAUDE report 7030724 ↗InjuryNov 14, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THAT, ALMOST 2 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #10, ITS NON-OSSEOINTEGRATION WAS OBSERVED. FORTY FIVE NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/ QUANTITY (BONE TYPE II), FENESTRATION OCCURRED DURING SURGERY AND BONE GRAFT WAS EXECUTED.
Patient problems: Tissue Damage; Unspecified Infection
MAUDE report 7029888 ↗InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT, 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #7, ITS NON- OSSEOINTEGRATION WAS OBSERVED. THIRTY-FIVE (35) NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE III.
Patient problems: Tissue Damage
MAUDE report 7019447 ↗InjuryNov 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(4) - THE DENTIST REPORTED HAVING TO REMOVE THE DENTAL IMPLANT AFTER ITS OSSEOINTEGRATION, BECAUSE THE ABUTMENT WAS SUBSTITUTED AND THE NEW ABUTMENT GOT STUCK INTO THE IMPLANT. AS IT WAS NOT POSSIBLE TO REMOVE ONLY THE ABUTMENT, THE IMPLANT WAS ALSO REMOVED.
Patient problems: Tissue Damage
MAUDE report 7018904 ↗InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #29, IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. THE PATIENT PRESENTED BONE TYPE III, 45 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED.
Patient problems: Tissue Damage
MAUDE report 7017089 ↗
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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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