Neodent 109.669Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · CM TITAMAX EX IMPLANT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Neodent Titamax dental implant is a screw-shaped implant placed in the jawbone to replace a missing tooth. Most of the 51 reports describe the implant failing to fuse with the surrounding bone, along with tissue damage, pain, swelling, and fistula. All 51 report injuries, and no deaths. There are no recalls.
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
- 51
- Deaths reported
- 0
- Injuries reported
- 51
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 07898237569161), received between Nov 8, 2017 and Mar 30, 2026 — classified as 51 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (43 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 Osseointegrate43
- Adverse Event Without Identified Device or Use Problem5
- Loss of Osseointegration3
Patient problems
- Tissue Damage34
- No Clinical Signs, Symptoms or Conditions14
- Pain8
- Swelling4
- Fistula3
- Unspecified Infection3
- Failure of Implant1
- Fibrosis1
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 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 24733669 ↗InjuryDec 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 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 23685851 ↗InjurySep 19, 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 23099576 ↗InjuryJul 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 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 22405150 ↗InjuryJun 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 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 22233863 ↗InjuryFeb 19, 2024Adverse 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 16, FAILURE OCCURRED UPON INSERTION. 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 18734244 ↗InjuryOct 12, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN FDI 13. DETAILS OF SURGERY: SINUS AUGMENTATION AND IMMEDIATE EXTRACTION SITE. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. 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 17926382 ↗InjuryFeb 13, 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 16368233 ↗InjuryFeb 13, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2022 IN THE PATIENTS 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 16368089 ↗InjuryJan 9, 2023Failure 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. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16126178 ↗InjuryApr 28, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 28. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE IV. 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 14242083 ↗InjuryMar 2, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN FDI 36. 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: Fibrosis
MAUDE report 13654486 ↗InjuryDec 30, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN FDI 33. 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 13120095 ↗InjuryDec 27, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN THE PATIENT'S MOUTH. 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 13089405 ↗InjuryMay 27, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN THE PATIENT'S MOUTH. 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 11895788 ↗InjuryMar 18, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 4. ON (B)(6) 202, 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 11518391 ↗InjuryMar 18, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 4. 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 11517712 ↗InjuryJun 22, 2020Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 13. DETAILS OF SURGERY: IMMEDIATE EXTRACTION SITE. ON (B)(6) 2019, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BRUXISM. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Tissue Damage
MAUDE report 10180804 ↗InjuryFeb 20, 2020Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT 20 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGIO ADA 22, ITS NON-OSSEOINTEGRATION WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED BONE TYPE III, BONE GRAFT WAS PLACED, IMMEDIATE IMPLANT WAS PERFORMED AND IMMEDIATE LOAD PROCEDURE WAS DONE.
Patient problems: Tissue Damage
MAUDE report 9734058 ↗InjuryNov 20, 2019Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THAT 1 MONTH AND 9 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON- OSSEOINTEGRATION WAS OBSERVED.
Patient problems: Tissue Damage
MAUDE report 9346377 ↗InjurySep 2, 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 THE DENTAL IMPLANT DURING ITS INSTALLATION SURGERY DUE TO PATIENT¿S CONDITIONS. MOREOVER, 60N.CM OF PRIMARY STABILITY WAS ACHIEVED.
Patient problems: Pain; Swelling; Tissue Damage
MAUDE report 8953838 ↗InjuryApr 8, 2019Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT ALMOST 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED.
Patient problems: Tissue Damage
MAUDE report 8490865 ↗InjuryOct 1, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT 1 MONTH AFTER THE DENTAL IMPLANT AND BRIDGE WERE PLACED IN ADA SITE 10 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN THIS OVER PREPPED SITE AND WAS REMOVED. A DIFFERENT IMPLANT WAS THEN PLACED. 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 7924092 ↗InjuryAug 29, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT 3 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 4 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE INTEGRATION IN TYPE III BONE. CLINICIAN REPORTS DEHISCENCE, FENESTRATION AND POOR HYGIENE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.
Patient problems: Tissue Damage
MAUDE report 7830335 ↗InjuryAug 29, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT NEARLY 1 MONTH AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED BONE TYPE II AND IMMEDIATE IMPLANT AND IMMEDIATE LOAD PROCEDURES WERES PERFORMED.
Patient problems: Tissue Damage
MAUDE report 7830074 ↗
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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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