Neodent 109.998Recalls & 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 implant is a root-form dental implant used as a tooth replacement anchor in the jaw. The 33 reports mostly describe the implant not fusing with the surrounding bone, or losing that bond after it had formed, leaving the implant mobile in the mouth; clinicians also mention tissue damage, pain, swelling, scarring and bleeding. All 33 reports are injuries, with no deaths. 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
- 33
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07899878023371), received between Jan 17, 2018 and Mar 2, 2026 — classified as 33 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (27 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 Osseointegrate27
- Adverse Event Without Identified Device or Use Problem5
- Loss of Osseointegration2
Patient problems
- Tissue Damage23
- No Clinical Signs, Symptoms or Conditions5
- Pain5
- Fibrosis4
- Swelling3
- Failure of Implant2
- Hemorrhage/Blood Loss/Bleeding2
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN FDI 14. 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 24488743 ↗InjuryFeb 22, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN ADA 12. ON (B)(6) 2020, NON-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: Fibrosis
MAUDE report 11361039 ↗InjuryFeb 22, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN ADA 12. ON (B)(6) 2020, NON-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: Fibrosis
MAUDE report 11359685 ↗InjuryFeb 18, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN ADA 19. ON (B)(6) 2021, NON-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: Fibrosis
MAUDE report 11344866 ↗InjuryFeb 18, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN ADA 19. ON (B)(6) 2021, NON-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: Fibrosis
MAUDE report 11344433 ↗InjuryJan 15, 2021Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN ADA 11. ON (B)(6) 2020, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR 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 11179696 ↗InjuryJan 15, 2021Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN ADA 11. ON (B)(6) 2020, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR 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 11179172 ↗InjuryAug 10, 2020Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN ADA 30. ON (B)(6) 2020, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Damage
MAUDE report 10387086 ↗InjuryAug 10, 2020Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN ADA 30. ON (B)(6) 2020, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Damage
MAUDE report 10386165 ↗InjuryFeb 13, 2020Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) ¿ THE DENTIST REPORTED THAT 2 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 30#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED BONE TYPE II.
Patient problems: Tissue Damage
MAUDE report 9707265 ↗InjuryFeb 3, 2020Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN ADA 30. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: Tissue Damage
MAUDE report 9661835 ↗InjuryDec 17, 2019Failure to Osseointegrate; Failure to Osseointegrate
(B)(4)¿ THE DENTIST REPORTED THAT 1 YEAR AND 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 23#, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 80N.CM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE II), IMMEDIATE IMPLANT WAS PERFORMED AND IMMEDIATE LOAD PROCEDURE WAS DONE.
Patient problems: Pain; Tissue Damage
MAUDE report 9481309 ↗InjuryDec 10, 2019Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN THE PATIENT'S MOUTH. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain; Swelling
MAUDE report 9448111 ↗InjuryDec 10, 2019Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN ADA 23. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THEMANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain
MAUDE report 9447927 ↗InjuryDec 6, 2019Failure to Osseointegrate; Failure to Osseointegrate
(B)(4)¿ THE DENTIST REPORTED THAT 3 MONTHS AND 21 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED BONE TYPE II, IMMEDIATE LOAD PROCEDURE WAS DONE.
Patient problems: Pain; Swelling; Tissue Damage
MAUDE report 9427860 ↗InjuryNov 13, 2019Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) ¿ THE DENTIST REPORTED THAT 2 MONTHS AND 25 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED BONE TYPE II.
Patient problems: Tissue Damage
MAUDE report 9315935 ↗InjuryOct 29, 2019Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT ALMOST 3 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE II BONE. THE CLINICIAN REPORTED THIS PATIENT WITH POOR ORAL HYGIENE HAS A BONE DEFECT. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Patient problems: Tissue Damage
MAUDE report 9250617 ↗InjurySep 6, 2019Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THAT 21 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 4#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED BONE TYPE III AND BONE GRAFT WAS PLACED.
Patient problems: Tissue Damage
MAUDE report 8968954 ↗InjuryAug 26, 2019Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT THREE WEEKS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 4 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE III BONE. THE CLINICIAN REPORTED THE PATIENT'S SWELLING. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Patient problems: Tissue Damage
MAUDE report 8929960 ↗InjuryJun 8, 2019Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED 8 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 13 IN THE PATIENT'S MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE II BONE. CLINICIAN NOTED THE PATIENT'S BONE DEFECT, BLEEDING AND POOR HYGIENE. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Damage
MAUDE report 8681249 ↗InjuryApr 19, 2019Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTED ALMOST 9 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN THE MOUTH, THE IMPLANT LOST OSSEOINTEGRATION. ANOTHER IMPLANT AND CROWN/ABUTMENT WERE PLACED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Patient problems: Tissue Damage
MAUDE report 8532574 ↗InjuryDec 21, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THE IMMEDIATE DENTAL IMPLANT PLACED IN ADA SITE 5 IN THE MOUTH DID NOT ACHIEVE OSSEOINTEGRATION IN TYPE IV BONE. THE IMPLANT WAS TORQUED MANUALLY TO 40 NCM. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Patient problems: Tissue Damage
MAUDE report 8192216 ↗InjuryDec 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(4) ¿ THE DENTIST REPORTED THAT THE DENTAL IMPLANT HAD TO BE REMOVED DURING ITS INSTALLATION SURGERY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Pain; Tissue Damage
MAUDE report 8164640 ↗InjuryOct 10, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT 2 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 9 IN THE MOUTH, THE IMPLANT FAILED TO ACHIEVE OSSEO- INTEGRATION. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Patient problems: Failure of Implant; Tissue Damage
MAUDE report 7953885 ↗InjurySep 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CLINICIAN REPORTED THAT ON THE DAY THE IMPLANT WAS PLACED IN ADA SITE 11 IN THE MOUTH, PRIMARY STABILITY WAS ACHIEVED, HOWEVER, CLINICIAN NOTED PATIENT'S INFECTION, MOBILITY, BLEEDING AND AN ABSCESS ON THAT DAY. ANOTHER IMPLANT WAS NOT PLACED ON THE SAME DAY IN SITE NOR WAS THE SITE GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Swelling; Unspecified Infection
MAUDE report 7899663 ↗
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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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