Neodent 140.685Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · CM DRIVE ACQUA IMPLANT · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Neodent CM Drive Acqua dental implant is a screw-shaped implant placed in the jawbone to support a replacement tooth. Of the 162 reports, many describe implants that did not fuse with the jawbone or lost their bond, and many mention tissue damage and pain. The reports include no deaths and 162 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 162
- Deaths reported
- 0
- Injuries reported
- 162
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 162 adverse event reports that list this exact device (DI 07899878016861), received between Nov 10, 2017 and May 6, 2026 — classified as 162 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (107 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 Osseointegrate107
- Loss of Osseointegration40
- Adverse Event Without Identified Device or Use Problem20
- Fracture2
- Insufficient Device Problem Information1
Patient problems
- Tissue Damage116
- Pain28
- Unspecified Infection27
- No Clinical Signs, Symptoms or Conditions22
- Fibrosis10
- Inflammation9
- Fistula6
- Hemorrhage/Blood Loss/Bleeding6
Recent adverse event reports
The 25 most recent of 162 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2025 IN FDI 36. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25103459 ↗InjuryApr 13, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. ON (B)(6) 2026, 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 24864869 ↗InjuryMar 9, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24551279 ↗InjuryNov 10, 2025Fracture; Fracture
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN FDI 26. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2025, FRACTURE OF THE IMPLANT WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. 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 23517800 ↗InjurySep 12, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN FDI 14. DETAILS OF SURGERY: SINUS AUGMENTATION. ON (B)(6) 2025, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE AND BRUXISM. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, PAIN, MOBILITY, BLEEDING AND ABSCESS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Abscess; Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 23041397 ↗InjuryJun 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 34. ON (B)(6) 2025, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis
MAUDE report 22246965 ↗InjuryApr 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN THE PATIENT'S MOUTH. ON (B)(6) 2025, 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 21745543 ↗InjuryMar 20, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN FDI 26. DETAILS OF SURGERY: SINUS AUGMENTATION AND IMMEDIATE EXTRACTION SITE. ON (B)(6) 2025, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. 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 21657016 ↗InjuryDec 9, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN THE PATIENT'S MOUTH. ON (B)(6) 2024 , 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 20887323 ↗InjuryAug 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN THE PATIENT'S MOUTH. ON (B)(6) 2024, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20053745 ↗InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 36. ON (B)(6) 2024 THE IMPLANT WAS REMOVED UPON CLINICIAN¿S DECISION. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19910991 ↗InjuryJul 8, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN ADA 19. ON (B)(6) 2024, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis
MAUDE report 19695213 ↗InjuryJul 8, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN ADA 19. ON (B)(6) 2024, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis
MAUDE report 19692130 ↗InjuryAug 7, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN ADA 3. ON (B)(6) 2023, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH INADEQUATE BONE QUALITY/QUANTITY. 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 17476870 ↗InjuryAug 7, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN ADA 3. ON (B)(6) 2023 , LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH INADEQUATE BONE QUALITY/QUANTITY. 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 17475112 ↗InjuryFeb 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN FDI 46. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND INCREASED SENSITIVITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Hyperresponsive to stimuli; Pain
MAUDE report 16296467 ↗InjuryNov 17, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2016 IN ADA 31. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, BLEEDING AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Unspecified Infection
MAUDE report 15821275 ↗InjuryNov 17, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2016 IN ADA 31. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, BLEEDING AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Unspecified Infection
MAUDE report 15817173 ↗InjuryNov 10, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2017 IN FDI 27. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 15775838 ↗InjurySep 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN THE PATIENT'S MOUTH. DETAILS OF SURGERY: SINUS PERFORATION AND IMMEDIATE EXTRACTION SITE. ON (B)(6) 2021, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III, POOR ORAL HYGIENE AND INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, SWELLING AND FISTULA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fistula; Sinus Perforation; Swelling/ Edema; Unspecified Infection
MAUDE report 15449898 ↗InjuryAug 26, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN ADA 19. ON (B)(6) 2021, 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 15304824 ↗InjuryAug 26, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN ADA 19. ON (B)(6) 2021 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 15303795 ↗InjuryAug 22, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 26. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. 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 15269148 ↗InjuryAug 15, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN FDI 26. ON (B)(6) 2022, 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 15228087 ↗InjuryAug 12, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN FDI 16. DETAILS OF SURGERY: SINUS AUGMENTATION. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, PAIN, MOBILITY AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Inflammation; Pain; Unspecified Infection
MAUDE report 15220150 ↗
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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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