Neodent 140.687Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · CM DRIVE ACQUA IMPLANT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Neodent CM Drive Acqua implant is a root-form dental implant used as a tooth replacement anchor in the jaw. The 37 reports mostly describe implants that failed to bond with the surrounding bone or lost that bond years after placement, along with tissue damage, pain, swelling and a couple of fractures. All 37 report injuries, with no deaths mentioned. 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
- 37
- Deaths reported
- 0
- Injuries reported
- 37
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 07899878016885), received between Nov 14, 2017 and Oct 21, 2024 — classified as 37 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (19 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
- Loss of Osseointegration19
- Failure to Osseointegrate12
- Adverse Event Without Identified Device or Use Problem6
- Fracture2
Patient problems
- Tissue Damage21
- Pain9
- Fibrosis7
- No Clinical Signs, Symptoms or Conditions6
- Unspecified Infection4
- Failure of Implant2
- Fistula2
- Swelling/ Edema2
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN FDI 26. ON (B)(6) 2024, LOSS OF 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 20495879 ↗InjurySep 6, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2016 IN ADA 29. ON (B)(6) 2024, 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 20160720 ↗InjurySep 6, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2016 IN ADA 29. ON (B)(6) 2024, 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 20159624 ↗InjuryJun 1, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN ADA 10. 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 17043064 ↗InjuryJun 1, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2018 IN ADA 10. 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 17040396 ↗InjuryDec 12, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2018 IN ADA 26. 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: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis
MAUDE report 15962687 ↗InjuryDec 12, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2018 IN ADA 26. 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: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis
MAUDE report 15961675 ↗InjuryMar 25, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2016 IN ADA 20. 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 13905915 ↗InjuryMar 25, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2016 IN ADA 20. 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 13905532 ↗InjuryMar 10, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN ADA 12. 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, MOBILITY, SWELLING AND FISTULA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Fistula; Pain; Swelling/ Edema
MAUDE report 13723565 ↗InjuryMar 10, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN ADA 12. 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, MOBILITY, SWELLING AND FISTULA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Fistula; Pain; Swelling/ Edema
MAUDE report 13723026 ↗InjuryOct 11, 2021Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN ADA 19. ON (B)(6) 2021, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain
MAUDE report 12609077 ↗InjuryOct 11, 2021Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN ADA 19. ON (B)(6) 2021, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain
MAUDE report 12607044 ↗InjuryJul 23, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN ADA 14. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2021, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III, FAIR ORAL HYGIENE AND INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 12219438 ↗InjuryJul 23, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN ADA 14. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2021, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III, FAIR ORAL HYGIENE AND INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 12218962 ↗InjuryOct 26, 2020Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN THE PATIENT'S MOUTH. ON (B)(6) 2020, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 10736327 ↗InjuryNov 11, 2019Loss of Osseointegration; Loss of Osseointegration
(B)(4) ¿ THE DENTIST REPORTED THAT 1 YEAR AND 2 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 4#, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED.
Patient problems: Tissue Damage
MAUDE report 9305668 ↗InjuryOct 28, 2019Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTED THAT OVER 14 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 4 IN THE PATIENT'S MOUTH, THE IMPLANT LOST OSSEOINTEGRATION. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Patient problems: Tissue Damage
MAUDE report 9245007 ↗InjuryMar 29, 2019Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTED 6.5 MONTHS AFTER THE IMMEDIATE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 13 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. THE IMPLANT WAS TORQUED TO 60 NCM. THE IMPLANT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Patient problems: Tissue Damage
MAUDE report 8467056 ↗InjuryMar 14, 2019Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) ¿ THE DENTIST REPORTED THAT 5 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 4#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 35N.CM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE II, BONE GRAFT WAS PLACED AND IMMEDIATE IMPLANT PROCEDURE WAS PERFORMED.
Patient problems: Tissue Damage; Unspecified Infection
MAUDE report 8422748 ↗InjuryFeb 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(4) ¿ THE DENTIST REPORTED THAT HAD TO REMOVE DENTAL IMPLANT DURING ITS INSTALLATION SURGERY BECAUSE IT DID NOT ACHIEVE A GOOD PRIMARY STABILITY. MOREOVER, THE PATIENT PRESENTED BONE TYPE II.
Patient problems: Tissue Damage
MAUDE report 8354989 ↗InjuryDec 20, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT ALMOST 5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 20 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE II BONE. CLINICIAN NOTED THE PATIENT'S INFECTION, PAIN, BLEEDING AND SWELLING. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Tissue Damage; Unspecified Infection
MAUDE report 8185466 ↗InjuryNov 13, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT 5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 13 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS. (B)(4).
Patient problems: Failure of Implant; Tissue Damage
MAUDE report 8065252 ↗InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CLINICIAN REPORTED THAT ON THE DAY THE IMMEDIATE IMPLANT WAS PLACED IN ADA SITE 31 IN THE MOUTH, PRIMARY STABILITY WAS NOT OBTAINED IN TYPE III BONE. CLINICIAN REPORTS INSUFFICIENT BONE QUALITY. ANOTHER IMPLANT WAS NOT PLACED IN THE SAME SITE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Patient problems: Tissue Damage
MAUDE report 8002635 ↗InjuryAug 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON THE DAY THE IMPLANT WAS PLACED IN ADA SITE 19 IN THE MOUTH, THERE WAS INSUFFICIENT BONE QUALITY/QUALITY. ANOTHER IMPLANT WAS NOT PLACED IN THE SAME SITE ON THE SAME DAY. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.
Patient problems: Tissue Damage
MAUDE report 7830332 ↗
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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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