Neodent 109.495Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07898237567594), received between Jun 29, 2026 and Jun 29, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).
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 Osseointegrate1
Patient problems
- Abscess1
- Fibrosis1
- Fistula1
- Hemorrhage/Blood Loss/Bleeding1
- Hyperresponsive to stimuli1
- Hypersensitivity/Allergic reaction1
- Inflammation1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 34. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PAIN, MOBILITY, BLEEDING, INCREASED SENSITIVITY, HYPERSENSITIVITY, ABSCESS, FISTULA AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Abscess; Fibrosis; Fistula; Hemorrhage/Blood Loss/Bleeding; Hyperresponsive to stimuli; Hypersensitivity/Allergic reaction; Inflammation; Pain; Unspecified Infection
MAUDE report 25657820 ↗
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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