Neodent 109.451Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · EXTERNAL HEX ZYGOMATIC IMPLANT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Neodent external hex zygomatic implant is a root-form dental implant used in the upper jaw. The 37 reports mostly describe implants that failed to bond with the surrounding bone or later lost that bond, sometimes alongside tissue damage, infection, an abscess, or bleeding. All 37 involve 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
- 37
- Deaths reported
- 0
- Injuries reported
- 37
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 07898237567297), received between Nov 9, 2017 and Jul 25, 2024 — classified as 37 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (20 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
- Loss of Osseointegration20
- Failure to Osseointegrate18
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Tissue Damage16
- No Clinical Signs, Symptoms or Conditions13
- Unspecified Infection8
- Fibrosis5
- Pain4
- Abscess2
- Hemorrhage/Blood Loss/Bleeding2
- Sinus Perforation2
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
InjuryJul 25, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 25. 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 19830590 ↗InjuryJul 25, 2024Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 14. 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 19830535 ↗InjuryMar 9, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN ADA 14. ON (B)(6) 2022 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 16515744 ↗InjuryMar 9, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2016 IN ADA 15. ON (B)(6) 2022, 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 16515653 ↗InjuryMar 9, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2017 IN ADA 14. ON (B)(6) 2022, 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 16514755 ↗InjuryMar 9, 2023Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2016 IN ADA 15. ON (B)(6) 2022, 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 16514666 ↗InjuryDec 2, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2021 IN ADA 13. DETAILS OF SURGERY: SINUS PERFORATION. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PERI-IMPLANTITIS AND ABSCESS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Abscess; Sinus Perforation; Unspecified Infection
MAUDE report 15908906 ↗InjuryDec 2, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 13. DETAILS OF SURGERY: SINUS PERFORATION. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PERI-IMPLANTITIS AND ABSCESS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Abscess; Sinus Perforation; Unspecified Infection
MAUDE report 15906647 ↗InjuryAug 2, 2022Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN FDI 24. ON (B)(6) 2022, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH POOR ORAL HYGIENE. 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 15150745 ↗InjuryJul 4, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN ADA 15. ON (B)(6) 2022, 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 14909523 ↗InjuryJul 4, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN ADA 15. ON (B)(6) 2022, 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 14907829 ↗InjuryMay 4, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 28. ON (B)(6) 2022, 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 14272644 ↗InjuryMay 4, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 28. ON (B)(6) 2022, 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 14272595 ↗InjuryMay 4, 2022Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2019 IN FDI 28. ON (B)(6) 2022, 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 14272452 ↗InjuryDec 13, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN FDI 13. 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 12987010 ↗InjuryDec 13, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN FDI 15. ON (B)(6) 2021, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. 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 12986982 ↗InjuryMay 3, 2021Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN ADA 3. ON (B)(6) 2021, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, MOBILITY AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Swelling/ Edema; Unspecified Infection
MAUDE report 11764281 ↗InjuryMay 3, 2021Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN ADA 3. ON (B)(6) 2021, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, MOBILITY AND SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Swelling/ Edema; Unspecified Infection
MAUDE report 11761962 ↗InjuryJan 4, 2021Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2014 IN FDI 14. ON (B)(6) 2020, LOSS OF OSSEOINTEGRATION WAS VERIFIED. 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 11111561 ↗InjuryJan 4, 2021Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2014 IN FDI 24. ON (B)(6) 2020, LOSS OF OSSEOINTEGRATION WAS VERIFIED. 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 11111553 ↗InjuryMay 19, 2020Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 15. ON (B)(6) 2020, NON-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; Tissue Damage
MAUDE report 10069158 ↗InjuryFeb 26, 2020Failure 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. MOREOVER, 45N.CM OF PRIMARY STABILITY WAS ACHIEVED AND THE PATIENT PRESENTED BONE TYPE II.
Patient problems: Tissue Damage
MAUDE report 9757843 ↗InjurySep 27, 2019Loss of Osseointegration; Loss of Osseointegration
(B)(4)- THE DENTIST REPORTED THAT 1 YEAR AND 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION 4#, ITS LOSS OF OSSEOINTEGRATION WAS OBSERVED. MOREOVER, 45N.CM OF PRIMARY STABILITY WAS ACHIEVED, THE PATIENT PRESENTED INSUFFICIENT BONE QUALITY/QUANTITY (BONE TYPE III) AND IMMEDIATE IMPLANT WAS PERFORMED. THE PATIENT HAS THE HABIT OF SMOKING.
Patient problems: Tissue Damage
MAUDE report 9127793 ↗InjurySep 4, 2019Loss of Osseointegration; Loss of Osseointegration
THE CLINICIAN REPORTED THAT ALMOST 1.5 YEARS AFTER THE DENTAL IMPLANT WAS PLACED IN ADA SITE 4 IN THE PATIENT'S MOUTH, THE IMPLANT LOST OSSEOINTEGRATION IN TYPE III BONE. THE CLINICIAN REPORTED THE PATIENT'S INSUFFICIENT BONE QUALITY. THE PRODUCT WILL BE FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS.
Patient problems: Tissue Damage
MAUDE report 8960058 ↗InjuryAug 28, 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 7#, ITS NON- OSSEOINTEGRATION WAS OBSERVED. MOREOVER, THE PATIENT PRESENTED BONE TYPE III.
Patient problems: Tissue Damage
MAUDE report 8941635 ↗
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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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