Neodent 109.494Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · SELF-DRILLING ANCHORAGE IMPLANT LB · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07898237567587), received between Mar 26, 2021 and Aug 5, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2 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.
Most reported problems
Device problems
- Failure to Osseointegrate2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 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 15178198 ↗InjuryNov 11, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 IN FDI 24. ON (B)(6) 2021, 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 12798475 ↗InjuryMar 26, 2021Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2020 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 11577258 ↗
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 109.488JJGC Indústria e Comércio de Materiais Dentários S/A. · Implant, endosseous, orthodontic7 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
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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