Neodent 109.488Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · SELF-DRILLING ANCHORAGE IMPLANT MB · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07898237567549), received between May 17, 2021 and Apr 27, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Fracture” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture4
- Failure to Osseointegrate3
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Fibrosis2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2026Fracture
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED IN THE PATIENT'S MOUTH. ON (B)(6) 2026, 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 25007202 ↗InjuryApr 27, 2026Fracture
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED IN THE PATIENT'S MOUTH. ON (B)(6) 2026, 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 25007195 ↗InjurySep 11, 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: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis
MAUDE report 17725119 ↗InjurySep 11, 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: MOBILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis
MAUDE report 17725115 ↗InjuryMar 20, 2023Fracture; Fracture
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED ON (B)(6) 2023 IN THE PATIENT'S MOUTH. 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 16579579 ↗InjuryAug 26, 2022Fracture; Fracture
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN THE PATIENT'S MOUTH. ON (B)(6) 2022, 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 15305139 ↗InjuryMay 17, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN FDI 23. 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 11836132 ↗
Other Implant, endosseous, orthodontic devices
- STRAUMANN ORTHOSYSTEM Palatal-SystemInstitut Straumann AG · Implant, endosseous, orthodontic328 reports
- STRAUMANN ORTHOSYSTEM Palatal-SystemInstitut Straumann AG · Implant, endosseous, orthodontic34 reports
- Neodent 109.496JJGC Indústria e Comércio de Materiais Dentários S/A. · Implant, endosseous, orthodontic9 reports
- Neodent 109.489JJGC Indústria e Comércio de Materiais Dentários S/A. · Implant, endosseous, orthodontic8 reports
- Neodent 109.487JJGC Indústria e Comércio de Materiais Dentários S/A. · Implant, endosseous, orthodontic7 reports
- Neodent 109.484JJGC Indústria e Comércio de Materiais Dentários S/A. · Implant, endosseous, orthodontic6 reports
- Neodent 109.498JJGC Indústria e Comércio de Materiais Dentários S/A. · Implant, endosseous, orthodontic4 reports
- Neodent 109.494JJGC Indústria e Comércio de Materiais Dentários S/A. · Implant, endosseous, orthodontic3 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page