Neodent 109.992Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · CM DRIVE IMPLANT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Neodent CM Drive dental implant is placed in the jawbone to hold a replacement tooth. Its 214 reports include 213 injuries and no deaths. Most reports describe the implant failing to fuse with the bone or losing that bond, and many mention tissue damage, pain and infection around it. 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
- 214
- Deaths reported
- 0
- Injuries reported
- 213
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 214 adverse event reports that list this exact device (DI 07899878023319), received between Nov 14, 2017 and Jun 17, 2025 — classified as 213 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (150 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate150
- Loss of Osseointegration37
- Adverse Event Without Identified Device or Use Problem31
- Fracture1
Patient problems
- Tissue Damage129
- Pain80
- Unspecified Infection70
- Fibrosis54
- Hemorrhage/Blood Loss/Bleeding51
- Inflammation25
- No Clinical Signs, Symptoms or Conditions18
- Swelling12
Recent adverse event reports
The 25 most recent of 214 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) 2017 IN ADA 28. ON (B)(6) 2023, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 22255537 ↗InjuryJun 17, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN ADA 28. ON (B)(6) 2023, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 22248897 ↗InjuryOct 31, 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 20581948 ↗InjuryJul 10, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN ADA 3. ON (B)(6) 2023, 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 17294715 ↗InjuryJul 10, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN ADA 3. ON (B)(6) 2023, 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 17289752 ↗InjuryMay 15, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2022 IN ADA 29. 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: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis
MAUDE report 16936036 ↗InjuryMay 15, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN ADA 29. 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: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis
MAUDE report 16931908 ↗InjuryApr 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN THE PATIENT'S MOUTH. ON (B)(6) 2023, 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 16670611 ↗InjuryNov 24, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2017 IN ADA 7. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE, BRUXISM AND INADEQUATE BONE QUALITY/QUANTITY. 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 15862908 ↗InjuryNov 24, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN ADA 7. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE, BRUXISM AND INADEQUATE BONE QUALITY/QUANTITY. 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 15861335 ↗InjurySep 1, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN ADA 13. 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 15339270 ↗InjurySep 1, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN ADA 13. 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 15338284 ↗InjuryApr 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 22. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV AND POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PAIN, MOBILITY AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 14046035 ↗InjuryApr 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 22. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND POOR ORAL HYGIENE. 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 14046021 ↗InjuryApr 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 27. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV AND POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PAIN, MOBILITY AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 14046016 ↗InjuryApr 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 7. ON (B)(6) 2021, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV AND POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PAIN, MOBILITY AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 14046012 ↗InjuryApr 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 22. ON (B)(6) 2021, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV AND POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PAIN, MOBILITY AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 14045997 ↗InjuryApr 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 29. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV AND POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PAIN, MOBILITY AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 14045994 ↗InjuryApr 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 10. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND POOR ORAL HYGIENE. 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 14045984 ↗InjuryApr 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 20. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV AND POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PAIN, MOBILITY AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 14045982 ↗InjuryApr 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 27. ON (B)(6) 2021, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV AND POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PAIN, MOBILITY AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 14045980 ↗InjuryApr 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 10. ON (B)(6) 2021, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV AND POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PAIN, MOBILITY AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 14045961 ↗InjuryApr 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 20. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV AND POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PAIN, MOBILITY AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 14045284 ↗InjuryApr 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 10. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND POOR ORAL HYGIENE. 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 14045273 ↗InjuryApr 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 29. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV AND POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PAIN, MOBILITY AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 14045268 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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