Neodent 109.739Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · FACILITY IMPLANT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Neodent dental implant is a root-form screw placed in the jawbone to replace a missing tooth. Most of the 36 reports describe implants that fail to fuse with the surrounding bone, or later lose that fusion, along with pain, swelling, tissue damage and one fracture. All 36 involve injuries, with no deaths reported. 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
- 36
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 07898237569529), received between Nov 9, 2017 and Apr 24, 2026 — classified as 36 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (27 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 Osseointegrate27
- Loss of Osseointegration5
- Adverse Event Without Identified Device or Use Problem4
- Fracture1
Patient problems
- Tissue Damage24
- Pain9
- No Clinical Signs, Symptoms or Conditions5
- Swelling3
- Fibrosis2
- Unspecified Infection2
- Failure of Implant1
- Hyperresponsive to stimuli1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
InjuryApr 24, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2015 IN THE PATIENT'S MOUTH. ON (B)(6) 2020, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain
MAUDE report 24986972 ↗InjuryMar 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN FDI 31. ON (B)(6) 2023, NON-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 16615871 ↗InjuryMar 4, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN FDI 22. ON (B)(6) 2019, LOSS OF OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PAIN AND MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Pain
MAUDE report 13670263 ↗InjuryJan 6, 2022Failure 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 13178600 ↗InjuryAug 9, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN FDI 41. DETAILS OF SURGERY: SINUS AUGMENTATION. ON (B)(6) 2021, 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 12297224 ↗InjuryMay 17, 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. 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 11836217 ↗InjuryFeb 15, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 13. ON (B)(6) 2020, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INCREASED SENSITIVITY AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Hyperresponsive to stimuli; Inflammation
MAUDE report 11329568 ↗InjuryFeb 15, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 23. ON (B)(6) 2020, 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 11329524 ↗InjuryDec 8, 2020Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2018 IN ADA 22. ON (B)(6) 2020, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. 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 10967229 ↗InjuryNov 30, 2020Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2015 IN THE PATIENT'S MOUTH. ON (B)(6) 2015, 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 10922610 ↗InjuryOct 23, 2020Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2016 IN FDI 41. ON (B)(6) 2016, NON-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 10729130 ↗InjuryOct 23, 2020Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN THE PATIENT'S MOUTH. ON (B)(6) 2019, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH POOR ORAL HYGIENE. 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 10729105 ↗InjuryFeb 19, 2020Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT ALMOST 2 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 8#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 45N.CM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE III, IMMEDIATE IMPLANT WAS PERFORMED AND IMMEDIATE LOAD PROCEDURE WAS DONE.
Patient problems: Tissue Damage
MAUDE report 9727108 ↗InjuryJul 24, 2019Failure to Osseointegrate; Failure to Osseointegrate
(B)(4)- THE DENTIST REPORTED THAT, 2 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN PATIENT¿S MOUTH, ITS NON-OSSEOINTEGRATION WAS OBSERVED.
Patient problems: Tissue Damage
MAUDE report 8823713 ↗InjuryJul 1, 2019Failure to Osseointegrate; Failure to Osseointegrate
(B)(4)¿ THE DENTIST REPORTED THAT 3 MONTHS AND 22 DAYS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 25#, ITS NON- OSSEOINTEGRATION WAS OBSERVED.
Patient problems: Tissue Damage
MAUDE report 8747804 ↗InjuryJun 13, 2019Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT ALMOST 2 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 32#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 50N.CM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE II, IMMEDIATE IMPLANT WAS PERFORMED AND IMMEDIATE LOAD PROCEDURE WAS DONE.
Patient problems: Tissue Damage
MAUDE report 8697801 ↗InjuryOct 28, 2018Failure 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. IN ADDITION, THE PATIENT PRESENTED BONE TYPE II.
Patient problems: Pain; Swelling; Tissue Damage
MAUDE report 8011213 ↗InjuryOct 10, 2018Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT ALMOST A MONTH AFTER THE DENTAL IMPLANT AND TEMPORARY CROWN/ABUTMENT WERE PLACED IN ADA SITE 10 IN THE MOUTH, THE IMPLANT DID NOT INTEGRATE IN TYPE III BONE. CLINICIAN REPORTS PATIENT'S POOR BONE QUALITY/QTY, TONGUE PRESSURE, BIOMECHANICAL OVERLOAD AND MOBILITY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Patient problems: Failure of Implant; Swelling; Tissue Damage
MAUDE report 7953872 ↗InjurySep 3, 2018Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
(B)(4) ¿ THE DENTIST REPORTED THAT DURING INSTALLATION SURGERY THE DENTAL IMPLANT GOT STUCK INTO THE BONE, THUS HE COULD NOT FINISH ITS INSTALLATION, BEING NECESSARY ITS REMOVAL. WHEN THE DENTIST WAS REMOVING THE DENTAL IMPLANT, ITS FRACTURE OCCURRED. THE PATIENT PRESENTED BONE TYPE II.
Patient problems: Tissue Damage
MAUDE report 7840999 ↗InjuryAug 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(4). THE DENTIST REPORTED THAT DENTAL IMPLANT HAD TO BE REMOVED DUE TO THE FRACTURE OF THE COMPONENT. MOREOVER, THE PATIENT PRESENTED BONE TYPE I AND BONE GRAFT WAS EXECUTED.
Patient problems: Tissue Damage
MAUDE report 7830092 ↗InjuryMay 25, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). - THE DENTIST REPORTED THAT 1 MONTH AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 5#, ITS NON-OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE III).
Patient problems: Pain; Tissue Damage; Unspecified Infection
MAUDE report 7545918 ↗InjuryMar 16, 2018Loss of Osseointegration; Loss of Osseointegration
(B)(4). THE DENTIST REPORTED THAT 2 YEARS AND 11 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #7, ITS NON- OSSEOINTEGRATION WAS OBSERVED. IN ADDITION, 32NCM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED BONE TYPE III AND THE PROCEDURES OF IMMEDIATE LOAD AND IMMEDIATE IMPLANT WERE PERFORMED. THE DENTIST ALSO REPORTED THAT OCCLUSAL OVERLOAD HAPPENED.
Patient problems: Tissue Damage
MAUDE report 7346855 ↗InjuryJan 12, 2018Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT 5 MONTHS AFTER DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #7,ITS NON-OSSEOINTEGRATION WAS OBSERVED. THIRTY-FIVE NCM OF PRIMARY STABILITY WAS ACHIEVED.
Patient problems: Tissue Damage
MAUDE report 7187137 ↗InjuryDec 7, 2017Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTED THAT 6 MONTHS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 26, OSSEOINTEGRATION HAD NOT YET BEEN OBTAINED. CLINICIAN NOTED MOBILITY SO THE IMPLANT WAS REMOVED AND ANOTHER ONE WAS PLACED. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS.
Patient problems: Tissue Damage
MAUDE report 7095230 ↗InjuryNov 16, 2017Failure to Osseointegrate; Failure to Osseointegrate
(B)(4). THE DENTIST REPORTED THAT, 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #25, ITS NON-OSSEOINTEGRATION WAS OBSERVED. A 35 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 7036711 ↗
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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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