Neodent 140.638Recalls & 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 Aqua dental implant is a screw-shaped implant used to replace missing teeth in the jawbone. Most of the 59 reports describe implants that failed to fuse with the surrounding bone, or lost that fusion later, sometimes with pain, tissue damage, infection, inflammation or bleeding, and one case of the implant breaking. There are 59 injuries and no deaths, and 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
- 59
- Deaths reported
- 0
- Injuries reported
- 59
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 07899878016571), received between Nov 9, 2017 and Jun 18, 2025 — classified as 59 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (39 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 Osseointegrate39
- Loss of Osseointegration18
- Adverse Event Without Identified Device or Use Problem6
- Fracture1
Patient problems
- Tissue Damage44
- Pain19
- Unspecified Infection7
- Fibrosis4
- No Clinical Signs, Symptoms or Conditions4
- Hemorrhage/Blood Loss/Bleeding3
- Inflammation3
- Swelling2
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
InjuryJun 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN THE PATIENT'S MOUTH. ON (B)(6) 2024, 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 22263510 ↗InjuryFeb 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN THE PATIENT'S MOUTH. 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: INFECTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 18644631 ↗InjuryMay 30, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN FDI 24. 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 17027538 ↗InjuryApr 21, 2023Failure 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: INFECTION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Unspecified Infection
MAUDE report 16790144 ↗InjuryDec 12, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 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 15963929 ↗InjuryDec 12, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 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 15961643 ↗InjuryAug 26, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN ADA 7. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Inflammation
MAUDE report 15305060 ↗InjuryAug 26, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN ADA 7. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Inflammation
MAUDE report 15304127 ↗InjuryApr 21, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN FDI 26. DETAILS OF SURGERY: RIDGE AUGMENTATION. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE AND 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 14171234 ↗InjuryApr 21, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN FDI 26. DETAILS OF SURGERY: RIDGE AUGMENTATION. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE AND 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 14169998 ↗InjuryOct 22, 2021Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN ADA 10. ON (B)(6) 2021, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE AND INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, PAIN, MOBILITY AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 12684221 ↗InjuryOct 22, 2021Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN ADA 10. ON (B)(6) 2021, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE AND INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, PAIN, MOBILITY AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 12683248 ↗InjuryFeb 17, 2020Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 30N.CM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE II AND IMMEDIATE IMPLANT WAS PERFORMED.
Patient problems: Tissue Damage
MAUDE report 9716962 ↗InjuryJan 10, 2020Loss of Osseointegration; Loss of Osseointegration
(B)(4) ¿ THE DENTIST REPORTED THAT 2 YEARS AND 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 13#, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 60N.CM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE II AND IMMEDIATE LOAD PROCEDURE WAS DONE.
Patient problems: Pain; Tissue Damage
MAUDE report 9576230 ↗InjuryDec 30, 2019Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN ADA 13. ON (B)(6) 2019, 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 9533010 ↗InjuryDec 9, 2019Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) ¿ THE DENTIST REPORTED THAT 3 MONTHS AND 12 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 8#, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 60N.CM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE II, BONE GRAFT WAS PLACED.
Patient problems: Pain; Swelling; Tissue Damage
MAUDE report 9437961 ↗InjuryOct 21, 2019Loss of Osseointegration; Loss of Osseointegration
(B)(4) - THE DENTIST REPORTED THAT 1 YEAR AND 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 19#, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED BONE TYPE III.
Patient problems: Tissue Damage; Unspecified Infection
MAUDE report 9213147 ↗InjuryJan 15, 2019Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT 11 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 2 IN THE MOUTH, THE IMPLANT LOST OSSEOINTEGRATION IN TYPE I BONE. THE IMPLANT WAS TORQUED MANUALLY TO 50 NCM. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS. RP.017748.
Patient problems: Tissue Damage
MAUDE report 8250655 ↗InjuryDec 5, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT 2 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #5, ITS NON-OSSEOINTEGRATION WAS OBSERVED. 45NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE III AND IMMEDIATE LOAD AND IMMEDIATE IMPLANT PROCEDURES WERE PERFORMED.
Patient problems: Pain; Tissue Damage
MAUDE report 8132896 ↗InjuryOct 8, 2018Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTED THAT OVER 1.5 YRS. AFTER THE DENTAL IMPLANT AND BRIDGE WERE PLACED IN ADA SITE 4 IN THE MOUTH, THE IMPLANT LOST OSSEO- INTEGRATION IN TYPE IV BONE. CLINICIAN NOTED PATIENT'S BONE RESORPTION, PAIN, MOBILITY, BLEEDING, INFLAMMATION AND ABSCESS. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Tissue Damage
MAUDE report 7944924 ↗InjuryAug 29, 2018Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration
THE CLINICIAN REPORTS THAT 16 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 26 IN THE MOUTH, THE IMPLANT LOST INTEGRATION IN TYPE II BONE. CLINICIAN REPORTS PAIN. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
Patient problems: Pain; Tissue Damage
MAUDE report 7830345 ↗InjuryJul 5, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT 2 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 23#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THE PATIENT PRESENTED BONE TYPE II AND 45NCM OF PRIMARY STABILITY WAS ACHIEVED.
Patient problems: Tissue Damage
MAUDE report 7663307 ↗InjuryJun 15, 2018Failure to Osseointegrate; Failure to Osseointegrate
HE CLINICIAN REPORTED THAT LESS THAN 6 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 10, THE IMPLANT HAD NOT OBTAINED INTEGRATION IN TYPE I BONE. CLINICIAN REPORTS PAIN AND BRUXISM. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS. (B)(4).
Patient problems: Pain
MAUDE report 7606509 ↗InjuryJun 14, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN (B)(6) SITE 20, THE IMPLANT HAD NOT ACHIEVED OSSEOINTEGRATION IN TYPE IV BONE. CLINICIAN REPORTS PAIN AND POOR BONE QUALITY/QUANTITY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS. (B)(4)
Patient problems: Pain
MAUDE report 7603183 ↗InjuryApr 16, 2018Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration
THE CLINICIAN REPORTED THAT 7 MONTHS AFTER THE DENTAL IMPLANT AND ABUTMENT WERE PLACED IN ADA SITE 7, THE IMPLANT HAD NOT ACHIEVED OSSEOINTEGRATION IN TYPE II BONE. CLINICIAN REPORTS DEFICIENT ORAL HYGIENE. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED COMPLICATIONS. (B)(4).
Patient problems: Tissue Damage
MAUDE report 7434543 ↗
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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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