Neodent 109.142Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · TITAMAX IMPLANT WITH MOUNT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07898237566672), received between Nov 8, 2017 and Nov 21, 2024 — classified as 20 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (15 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 Osseointegrate15
- Loss of Osseointegration3
- Fracture2
Patient problems
- Tissue Damage18
- No Clinical Signs, Symptoms or Conditions2
- Complaint, Ill-Defined1
- Failure of Implant1
- Unspecified Infection1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2024Fracture; Fracture
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2012 IN THE PATIENT'S MOUTH. ON (B)(6) 2024, 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 20749990 ↗InjurySep 21, 2020Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 14. ON (B)(6) 2020, 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; Tissue Damage
MAUDE report 10562247 ↗InjuryAug 10, 2020Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2009 IN THE PATIENT'S MOUTH. ON (B)(6) 2009, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Patient problems: Tissue Damage
MAUDE report 10387106 ↗InjuryOct 29, 2019Failure to Osseointegrate; Failure to Osseointegrate
(B)(4)¿ THE DENTIST REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED.
Patient problems: Tissue Damage
MAUDE report 9248978 ↗InjuryOct 28, 2019Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) ¿ THE DENTIST REPORTED THAT 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED.
Patient problems: Tissue Damage
MAUDE report 9247267 ↗InjuryMay 31, 2019Fracture; Fracture
(B)(4) - THE DENTIST REPORTED THAT, 9 YEARS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #24, ITS FRACTURE WAS OBSERVED. THE PATIENT PRESENTED BONE TYPE I.
Patient problems: Failure of Implant; Tissue Damage
MAUDE report 8658713 ↗InjuryAug 29, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) ¿ THE DENTIST REPORTED THAT AFTER DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Tissue Damage
MAUDE report 7830017 ↗InjuryAug 29, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THE NON-OSSEOINTEGRATION OF THE DENTAL IMPLANT. IN TELEPHONE CONTACT, THE DENTIST REPORTED THAT HE MADE THE COMPLAINT AFTER ACCUMULATING IMPLANTS FROM DIFFERENT PATIENTS FOR YEARS AND, THEREFORE, HAD NO INFORMATION ABOUT THE PATIENT, SURGICAL TECHNIQUE OR DEVICE BATCH.
Patient problems: Tissue Damage
MAUDE report 7829646 ↗InjuryMay 18, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THAT AFTER 4 MONTHS DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 10#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 32NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE III AND IMMEDIATE IMPLANT PROCEDURE WAS PERFORMED.
Patient problems: Tissue Damage
MAUDE report 7527168 ↗InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THAT, AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Tissue Damage
MAUDE report 7022308 ↗InjuryNov 10, 2017Loss of Osseointegration; Loss of Osseointegration
(B)(4) - THE DENTIST REPORTED THAT, 7 YEARS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #7, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. A 45 NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE IV.
Patient problems: Tissue Damage
MAUDE report 7021975 ↗InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THAT, 3 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #28, ITS NON-OSSEOINTEGRATION WAS OBSERVED. FORTY-FIVE NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE II.
Patient problems: Tissue Damage
MAUDE report 7021694 ↗InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THAT, AFTER THE DENTAL IMPLANT WAS 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. THIRTY-FIVE NCM OF PRIMARY STABILITY WAS ACHIEVED.
Patient problems: Tissue Damage
MAUDE report 7020510 ↗InjuryNov 10, 2017Loss of Osseointegration; Loss of Osseointegration
(B)(4). THE DENTIST REPORTED THAT, 2 YEARS AND 7 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. 60 NCM OF PRIMARY STABILITY WAS ACHIEVED AND THE IMPLANT WAS INSTALLED WITHOUT IMMEDIATELY LOAD. THE PATIENT PRESENTED BONE TYPE III.
Patient problems: Tissue Damage
MAUDE report 7020298 ↗InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THE OSSEOINTEGRATION FAILURE OF TWO DENTAL IMPLANTS, BUT DID NOT PROVIDE INFORMATION ABOUT THE CASE.
Patient problems: Complaint, Ill-Defined
MAUDE report 7019011 ↗InjuryNov 10, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4) - THE DENTIST REPORTED THAT 9 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #8, IT WAS VERIFIED ITS LOSS OF OSSEOINTEGRATION. THIRTY NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED. THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/ QUANTITY (BONE TYPE III) AND FENESTRATION OCCURRED DURING SURGERY.
Patient problems: Tissue Damage; Unspecified Infection
MAUDE report 7018557 ↗InjuryNov 9, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #7 IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. 45 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS EXECUTED. THE PATIENT PRESENTED BONE TYPE III.
Patient problems: Tissue Damage
MAUDE report 7012960 ↗InjuryNov 9, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #25 IT WAS VERIFIED ITS NON- OSSEOINTEGRATION. 45 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED. THE PATIENT PRESENTED BONE TYPE I.
Patient problems: Tissue Damage
MAUDE report 7012923 ↗InjuryNov 9, 2017Failure to Osseointegrate; Failure to Osseointegrate
OS 111910 - THE DENTIST REPORTED THAT 1 MONTH AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT'S MOUTH IT WAS VERIFIED ITS NON-OSSEOINTEGRATION, BUT NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Tissue Damage
MAUDE report 7012697 ↗InjuryNov 8, 2017Failure to Osseointegrate; Failure to Osseointegrate
OS (B)(4) - THE DENTIST REPORTED THAT 20 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #28 IT WAS VERIFIED ITS NON-OSSEOINTEGRATION . THE 32 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT EXECUTED.
Patient problems: Tissue Damage
MAUDE report 7010763 ↗
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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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