Neodent 109.610Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · CM TITAMAX IMPLANT · Class 2 · Implant
Quick summary
This Neodent Titamax dental implant has 120 adverse event reports, with 120 injuries and no deaths. Most describe the implant failing to bond with the jawbone, and some describe tissue damage, infection, pain and swelling. 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
- 121
- Deaths reported
- 0
- Injuries reported
- 121
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 07898237568621), received between Nov 8, 2017 and Sep 7, 2026 — classified as 121 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (88 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate88
- Loss of Osseointegration27
- Adverse Event Without Identified Device or Use Problem5
- Fracture1
Patient problems
- Tissue Damage48
- Unspecified Infection37
- Pain32
- Fibrosis27
- No Clinical Signs, Symptoms or Conditions25
- Swelling/ Edema9
- Fistula7
- Inflammation3
Recent adverse event reports
The 25 most recent of 121 reports, in the reporter's own words as published by the FDA.
InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50656169 ↗InjuryMay 7, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6)2025 IN FDI 15. ON (B)(6)2026, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BRUXISM. 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 25115262 ↗InjuryDec 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 44. ON (B)(6) 2025, 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 23870375 ↗InjuryNov 21, 2025Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN FDI 44. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE AND SINUS AUGMENTATION. ON (B)(6) 2024, 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 23621440 ↗InjuryNov 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 44. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2025, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN, MOBILITY, BLEEDING AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain
MAUDE report 23609116 ↗InjuryJun 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 45. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. 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: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain
MAUDE report 22276857 ↗InjuryNov 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN FDI 22. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON 2024-07-02, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INCREASED SENSITIVITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Hyperresponsive to stimuli
MAUDE report 20812082 ↗InjurySep 27, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN THE PATIENT'S MOUTH. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 20326387 ↗InjurySep 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN THE PATIENT'S MOUTH. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, PAIN AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 20325985 ↗InjurySep 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN THE PATIENT'S MOUTH. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, PAIN AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 20325863 ↗InjurySep 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN THE PATIENT'S MOUTH. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 20325857 ↗InjurySep 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN THE PATIENT'S MOUTH. ON (B)(6) 2023, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, PAIN, MOBILITY AND FISTULA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Fistula; Pain; Unspecified Infection
MAUDE report 20324962 ↗InjurySep 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN FDI 31. ON (B)(6) 2023, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 20262349 ↗InjuryJul 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN FDI 24. ON (B)(6) 2024, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND INADEQUATE BONE QUALITY/QUANTITY. 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 19695567 ↗InjuryJun 21, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN THE PATIENT'S MOUTH. ON (B)(6) 2023, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, PAIN AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 19586659 ↗InjuryJun 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN FDI 35. ON (B)(6) 2024, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: FISTULA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fistula
MAUDE report 19540697 ↗InjuryMay 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN FDI 22. ON (B)(6) 2024 NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV. 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 19364540 ↗InjuryFeb 29, 2024Failure 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 18810533 ↗InjuryFeb 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN FDI 32. ON (B)(6) 2021, 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 18690062 ↗InjuryNov 20, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED 2013-(B)(6) IN THE PATIENT'S MOUTH. ON 2023-(B)(6) LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, PAIN AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 18178732 ↗InjuryNov 2, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN FDI 44. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2023, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN, SWELLING AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Inflammation; Pain; Swelling/ Edema
MAUDE report 18062038 ↗InjuryOct 2, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN FDI 13. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. 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 17857490 ↗InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CLINICIAN REPORTS THAT THE DAY THE IMPLANT WAS PLACED IN FDI 44, FAILURE OCCURRED UPON INSERTION. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMMEDIATE EXTRACTION SITE. PATIENT PRESENTED WITH BONE TYPE IV AND INADEQUATE BONE QUALITY/QUANTITY. 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 17714163 ↗InjuryAug 17, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 45. ON (B)(6) 2023, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Swelling/ Edema
MAUDE report 17567279 ↗InjuryAug 17, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6)2019 IN FDI 43. ON (B)(6)2023, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH POOR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Swelling/ Edema
MAUDE report 17566947 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.