Neodent 140.640Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · CM TITAMAX EX ACQUA IMPLANT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Neodent Titamax Ex Acqua dental implant is a screw-shaped implant placed into the jawbone to replace a missing tooth. The 34 reports mostly describe implants that failed to bond with the surrounding bone or later lost that bond, along with tissue damage, pain, swelling, infection and fistula. All 34 reports describe 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
- 34
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 07899878016595), received between Nov 14, 2017 and Sep 6, 2024 — classified as 34 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (23 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 Osseointegrate23
- Loss of Osseointegration10
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Tissue Damage27
- Pain12
- Failure of Implant7
- Unspecified Infection7
- Fistula5
- Swelling5
- Sinus Perforation3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
InjurySep 6, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2016 IN ADA 26. 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 20161052 ↗InjurySep 6, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2016 IN ADA 26. 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 20159480 ↗InjuryFeb 8, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN THE PATIENT'S MOUTH. ON (B)(6) 2020, 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: INFECTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 11296283 ↗InjuryJan 30, 2020Loss of Osseointegration; Loss of Osseointegration
(B)(4)¿ THE DENTIST REPORTED THAT 3 YEARS AND 6 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 23#, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 60N.CM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE IV.
Patient problems: Fistula; Pain; Tissue Damage
MAUDE report 9647786 ↗InjuryJan 21, 2020Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2016 IN ADA 23. ON (B)(6) 2019, 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, SWELLING AND FISTULA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fistula; Pain; Swelling
MAUDE report 9613649 ↗InjuryDec 28, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT 19 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 45NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE II AND IMMEDIATE IMPLANT AND IMMEDIATE LOAD PROCEDURES WERE PERFORMED.
Patient problems: Pain; Tissue Damage; Unspecified Infection
MAUDE report 8204713 ↗InjuryNov 7, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT 1.5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 26 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. THE SITE WAS GRAFTED. 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 8048697 ↗InjuryNov 7, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT 1.5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 13 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. THE SITE WAS GRAFTED. 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 8048695 ↗InjuryNov 7, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT 1.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 20 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. THE SITE WAS GRAFTED. 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 8048691 ↗InjuryNov 7, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT 1.5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 4 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. THE SITE WAS GRAFTED. 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 8048687 ↗InjuryNov 6, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT ALMOST 5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 13 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE OSSEOINTEGRATION. CLINICIAN NOTED PATIENT'S PAIN, MOBILITY AND BRUXISM. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
Patient problems: Failure of Implant; Pain; Tissue Damage
MAUDE report 8044047 ↗InjuryOct 16, 2018Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration
THE CLINICIAN REPORTED THAT 1.5 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 4 IN THE MOUTH, THE IMPLANT LOST OSSEOINTEGRATION. CLINICIAN NOTED PATIENT'S BRUXISM. 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 7971413 ↗InjuryOct 11, 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 2 IN THE PATIENT'S MOUTH. PRIMARY STABILITY WAS NOT ACHIEVED. THE SITE WAS NOT GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. THERE WERE NOT REPORTED PATIENT COMPLICATIONS.
Patient problems: Tissue Damage
MAUDE report 7957331 ↗InjurySep 17, 2018Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration
THE CLINICIAN REPORTED THAT NEARLY 1 YEAR AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 23 IN THE MOUTH, THE IMPLANT LOST OSSEOINTEGRATION IN TYPE II BONE. CLINICIAN REPORTS PATIENT'S PAIN. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
Patient problems: Failure of Implant; Pain; Tissue Damage
MAUDE report 7883223 ↗InjuryAug 29, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THAT 3.5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 20 IN THE MOUTH, THE IMPLANT DID NOT ACHIEVE INTEGRATION IN TYPE III BONE. THE SITE WAS NOT GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS.
Patient problems: Tissue Damage
MAUDE report 7830349 ↗InjuryJun 14, 2018Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTED THAT 2.5 YEARS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 13 IN THE MOUTH, THE IMPLANT LOST OSSEOINTEGRATION IN TYPE I BONE. CLINICIAN REPORTS SMOKING AND BRUXISM. THE SITE WAS GRAFTED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS. (B)(4).
Patient problems: Tissue Damage
MAUDE report 7603186 ↗InjuryMar 2, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT, JUST OVER 3 MONTHS AFTER THE IMPLANT WAS PLACED IN SITE 13, AN OSSEOINTEGRATION FAILURE WAS OBSERVED. THE 35+ NCM OF TORQUE WAS APPLIED TO THE IMPLANT AT THE TIME OF SURGERY. THE BONE QUALITY WAS DETERMINED TO BE TYPE III. THE DEVICE WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Patient problems: Tissue Damage
MAUDE report 7310992 ↗InjuryFeb 8, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT 20 DAYS AFTER DENTAL IMPLANT WAS INSTALLED IN MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. A 35 NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITH IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE IV.
Patient problems: Sinus Perforation; Tissue Damage; Unspecified Infection
MAUDE report 7251536 ↗InjuryFeb 7, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT 5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 29, THE IMPLANT LOST OSSEOINTEGRATION. CLINICIAN REPORTS PAIN. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST- OPERATIVE COMPLICATIONS. (B)(4).
Patient problems: Pain; Tissue Damage
MAUDE report 7247483 ↗InjuryFeb 7, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT ALMOST 6 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 26, THE IMPLANT LOST OSSEOINTEGRATION. CLINICIAN NOTED PAIN AND MOBILITY, THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
Patient problems: Pain; Tissue Damage
MAUDE report 7247459 ↗InjuryFeb 7, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT LESS THAN 5 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN SITE 4, THE IMPLANT LOST OSSEOINTEGRATION. CLINICIAN REPORTED MOBILITY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS. (B)(4).
Patient problems: Tissue Damage
MAUDE report 7247367 ↗InjuryFeb 1, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT 15 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. 35 NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITH IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE IV.
Patient problems: Pain; Tissue Damage
MAUDE report 7235268 ↗InjuryJan 2, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT NEARLY 2 MONTHS AFTER THE DENTAL IMPLANT IN ADA SITE 14 WAS PLACED, THE IMPLANT HAD NOT YET INTEGRATED IN TYPE III BONE. CLINICIAN REPORTS AN INFECTION, PAIN, FISTULA AND SWELLING. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
Patient problems: Fistula; Swelling; Unspecified Infection
MAUDE report 7157405 ↗InjuryJan 2, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT NEARLY 2 MONTHS AFTER THE DENTAL IMPLANT IN ADA SITE 10 WAS PLACED, THE IMPLANT HAD NOT YET INTEGRATED IN TYPE III BONE. CLINICIAN REPORTS AN INFECTION, PAIN, FISTULA AND SWELLING. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
Patient problems: Fistula; Swelling; Unspecified Infection
MAUDE report 7157374 ↗InjuryJan 2, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT NEARLY 2 MONTHS AFTER THE DENTAL IMPLANT IN ADA SITE 7 WAS PLACED, THE IMPLANT HAD NOT YET INTEGRATED IN TYPE III BONE. CLINICIAN REPORTS AN INFECTION, PAIN, FISTULA AND SWELLING. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
Patient problems: Fistula; Swelling; Unspecified Infection
MAUDE report 7157368 ↗
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- 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 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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