Neodent 109.141Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · TITAMAX IMPLANT WITH MOUNT · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Neodent Titamax dental implant is a screw-shaped root-form implant used to replace missing teeth. The 30 reports describe implants that either failed to fuse with the jawbone or, in some cases years later, broke or lost that bond, along with tissue damage, pain, swelling and infection. No deaths were reported and all 30 reports involved injuries. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 07898237566665), received between Nov 8, 2017 and Aug 5, 2024 — classified as 30 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (18 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate18
- Fracture7
- Loss of Osseointegration4
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Tissue Damage25
- Pain8
- Unspecified Infection6
- No Clinical Signs, Symptoms or Conditions4
- Swelling2
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 2024Fracture; Fracture
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2007 IN FDI 12. ON (B)(6) 2024, FRACTURE OF THE IMPLANT WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19910998 ↗InjuryJul 19, 2024Fracture; Fracture
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2005 IN FDI 26. ON (B)(6) 2023, FRACTURE OF THE IMPLANT 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 19781608 ↗InjuryJun 17, 2024Fracture; Fracture
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 45. ON (B)(6) 2024, FRACTURE OF THE IMPLANT WAS VERIFIED. PATIENT PRESENTED WITH BRUXISM. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. THERE WERE NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19552317 ↗InjuryJul 28, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2011 IN FDI 42. ON (B)(6) 2023, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BRUXISM. 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 17416862 ↗InjurySep 21, 2020Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2010 IN FDI 34. ON (B)(6) 2010, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION AND PAIN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Pain; Unspecified Infection
MAUDE report 10562239 ↗InjuryAug 29, 2018Fracture; Fracture
(B)(4) ¿ THE DENTIST REPORTED THAT 5 YEARS AND 2 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 4#, ITS FRACTURE OCCURRED. IN ADDITION, 20 NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE III AND BIOMECHANICAL OVERLOAD HAS HAPPENED.
Patient problems: Tissue Damage
MAUDE report 7829756 ↗InjuryMay 3, 2018Fracture; Fracture
(B)(4) - THE DENTIST REPORTED THAT AFTER 5 YEARS AND 8 MONTHS DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 6#, HE HAD TO REMOVE IT BECAUSE OF ITS FRACTURE. IN ADDITION, THE PATIENT PRESENTED BONE TYPE IV AND BONE GRAFT WAS EXECUTED.
Patient problems: Pain; Swelling; Tissue Damage
MAUDE report 7483179 ↗InjuryMay 3, 2018Fracture; Fracture
(B)(4) - THE DENTIST REPORTED THAT AFTER 5 YEARS AND 8 MONTHS DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 10#, HE HAD TO REMOVE IT BECAUSE OF ITS FRACTURE. IN ADDITION, THE PATIENT PRESENTED BONE TYPE IV AND BONE GRAFT WAS EXECUTED.
Patient problems: Pain; Swelling; Tissue Damage
MAUDE report 7483178 ↗InjuryApr 19, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(6) - THE DENTIST REPORTED THAT AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, PATIENT PRESENTED BONE TYPE II AND PERI-IMPLANTITIS..
Patient problems: Pain; Tissue Damage; Unspecified Infection
MAUDE report 7443649 ↗InjuryNov 13, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT 5 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #4 IT WAS VERIFIED ITS NON-OSSEOINTEGRATION. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Tissue Damage
MAUDE report 7024189 ↗InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THAT, AFTER TWO DENTAL IMPLANTS WERE INSTALLED IN PATIENT¿S MOUTH, AT THE TIME OF UNCOVERING TO PERFORM THE PATIENT¿S PROSTHETIC REHABILITATION, IT WAS SEEN THAT THE DENTAL IMPLANT HAD NOT OSSEOINTEGRATED. THE 35 NCM OF PRIMARY STABILITY WAS ACHIEVED.
Patient problems: Tissue Damage
MAUDE report 7020466 ↗InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THAT, 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #14, ITS NON-OSSEOINTEGRATION WAS OBSERVED. THIRTY NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE INSUFFICIENT BONE QUALITY/ QUANTITY (BONE TYPE IV).
Patient problems: Tissue Damage
MAUDE report 7020350 ↗InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THAT, ALMOST 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. FIFTEEN NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOADING. THE PATIENT PRESENTED BONE TYPE III.
Patient problems: Tissue Damage
MAUDE report 7019954 ↗InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THAT, ALMOST 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. FIFTEEN NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOADING. THE PATIENT PRESENTED BONE TYPE III.
Patient problems: Tissue Damage
MAUDE report 7019949 ↗InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT TWO DENTAL IMPLANTS DID NOT OSSEOINTEGRATED AFTER INSTALLATION IN PATIENT¿S MOUTH. THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY.
Patient problems: Tissue Damage
MAUDE report 7019627 ↗InjuryNov 10, 2017Fracture; Fracture
(B)(4). THE DENTIST REPORTED THAT, 11 YEARS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #29; ITS FRACTURE WAS OBSERVED.
Patient problems: Pain; Tissue Damage
MAUDE report 7019054 ↗InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THAT 15 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #28 IT WAS VERIFIED ITS NON OSSEOINTEGRATION. IMMEDIATE LOAD WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Tissue Damage
MAUDE report 7017404 ↗InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT 24 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #21, IT WAS VERIFIED ITS NON-OSSEOINTEGRATION. A 32 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS PERFORMED.
Patient problems: Tissue Damage
MAUDE report 7017396 ↗InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT 20 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #26, IT WAS VERIFIED ITS NON-OSSEOINTEGRATION. THIRTY TWO NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS PERFORMED.
Patient problems: Tissue Damage
MAUDE report 7017395 ↗InjuryNov 9, 2017Loss of Osseointegration; Loss of Osseointegration
(B)(4). THE DENTIST REPORTED THAT 4 YEARS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #3 IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. A 25 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED. THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE IV).
Patient problems: Pain; Tissue Damage
MAUDE report 7013220 ↗InjuryNov 9, 2017Loss of Osseointegration; Loss of Osseointegration
(B)(4) - THE DENTIST REPORTED THAT 3 YEARS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT'S MOUTH IT WAS VERIFIED ITS LOSS OF OSSEOINTEGRATION. PATIENT PRESENTED BONE TYPE III AND IMMEDIATE LOAD WAS NOT PERFORMED.
Patient problems: Tissue Damage; Unspecified Infection
MAUDE report 7013097 ↗InjuryNov 9, 2017Loss of Osseointegration; Loss of Osseointegration
RP.000222 - THE DENTIST REPORTED THAT 6 YEARS AFTER TWO DENTAL IMPLANTS WERE INSTALLED IN INTRAORAL REGIONS #19 AND #18, IT WAS VERIFIED THEIR LOSS OF OSSEOINTEGRATION. PATIENT PRESENTED BONE TYPE III.
Patient problems: Pain; Tissue Damage; Unspecified Infection
MAUDE report 7013009 ↗InjuryNov 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(4) - THE DENTIST REPORTED THAT 2 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #7 IT WAS VERIFIED ITS FRACTURE.
Patient problems: Pain; Tissue Damage; Unspecified Infection
MAUDE report 7012930 ↗InjuryNov 9, 2017Failure to Osseointegrate; Failure to Osseointegrate
OS 112213 - THE DENTIST REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #24 IT WAS VERIFIED ITS NON-OSSEOINTEGRATION. FORTY-FIVE NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED.
Patient problems: Tissue Damage
MAUDE report 7012772 ↗InjuryNov 9, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THAT SIX MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT'S MOUTH IT WAS VERIFIED ITS NON-OSSEOINTEGRATION. BONE GRAFT WAS EXECUTED.
Patient problems: Tissue Damage
MAUDE report 7012663 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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