Neodent 109.496Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · SELF-DRILLING ANCHORAGE IMPLANT MB · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07898237567600), received between Aug 21, 2023 and Aug 31, 2026 — classified as 9 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (8 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 Osseointegrate8
- Fracture1
Patient problems
- Fibrosis8
- Inflammation6
- Hemorrhage/Blood Loss/Bleeding2
- Pain1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2026Fracture
Patient problems: Pain
MAUDE report 50530287 ↗InjuryDec 8, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN ADA 2. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2023, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding
MAUDE report 18297075 ↗InjuryDec 8, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN ADA 2. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON 2023-11-06, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY AND BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding
MAUDE report 18294270 ↗InjurySep 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN ADA 3. ON (B)(6) 2023, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Inflammation
MAUDE report 17769114 ↗InjurySep 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN ADA 3. ON (B)(6) 2023, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Inflammation
MAUDE report 17766228 ↗InjuryAug 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS, THE IMPLANT WAS INSERTED (B)(6) 2023 IN ADA 2. ON (B)(6) 2023, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT, THE PATIENT EXPERIENCED: MOBILITY AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Inflammation
MAUDE report 17591112 ↗InjuryAug 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS, THE IMPLANT WAS INSERTED (B)(6) 2023 IN ADA 2. ON (B)(6) 2023, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT, THE PATIENT EXPERIENCED: MOBILITY AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Inflammation
MAUDE report 17591104 ↗InjuryAug 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN ADA 2. ON (B)(6) 2023, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Inflammation
MAUDE report 17586602 ↗InjuryAug 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN ADA 2. ON (B)(6) 2023, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: MOBILITY AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Fibrosis; Inflammation
MAUDE report 17586592 ↗
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 109.489JJGC 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
- 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 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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