Neodent 140.956Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · GM HELIX ACQUA IMPLANT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Neodent GM Helix Acqua bone implant has 755 reports, with no deaths and 755 injuries. Most reports describe the implant failing to bond with the bone or losing that bond later, and some mention inflammation around the implant and loosening. 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
- 760
- Deaths reported
- 0
- Injuries reported
- 760
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 760 adverse event reports that list this exact device (DI 07899878025016), received between Oct 11, 2018 and Sep 16, 2026 — classified as 760 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (454 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 Osseointegrate454
- Loss of Osseointegration199
- Adverse Event Without Identified Device or Use Problem70
- Difficult to Insert32
- Fracture6
Patient problems
- No Clinical Signs, Symptoms or Conditions353
- Fibrosis211
- Pain167
- Unspecified Infection128
- Hemorrhage/Blood Loss/Bleeding50
- Inflammation49
- Tissue Damage48
- Swelling/ Edema44
Recent adverse event reports
The 25 most recent of 760 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 26. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III and inadequate bone quality/quantity. No product was returned to the manufacturer. At the event the patient experienced: Pain. No further patient complications were reported.
Patient problems: Pain
MAUDE report 50792226 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762477 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 4, failure occurred upon insertion. 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 50758083 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Abscess; Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Unspecified Infection
MAUDE report 50720484 ↗InjurySep 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 22. Details of surgery: Immediate extraction site. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Infection, Pain, Bleeding, Abscess and Inflammation. No further patient complications were reported.
Patient problems: Abscess; Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Unspecified Infection
MAUDE report 50718749 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50656331 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50656153 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50655899 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50655592 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50653234 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50653113 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653097 ↗InjuryAug 24, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in ADA 4. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type IV. 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 50417736 ↗InjuryAug 24, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6)2024 in FDI 16. On (b)(6)2026, loss of osseointegration was verified. Patient presented with bone type III. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis and Pain. No further patient complications were reported.
Patient problems: Pain; Unspecified Infection
MAUDE report 50417704 ↗InjuryAug 24, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in the patient's mouth. On (B)(6) 2026, 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 50417348 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50417087 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50417086 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50413507 ↗InjuryAug 24, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2025 in ADA 2. Details of surgery: Primary stability not achieved. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Infection and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50413122 ↗InjuryAug 24, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2025 in ADA 3. Details of surgery: Primary stability not achieved. On (B)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Infection and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50413095 ↗InjuryAug 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50285073 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in the patient's mouth. On (b)(6) 2026, 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 50281247 ↗InjuryAug 3, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50121476 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 5, failure occurred upon insertion. Patient presented with inadequate bone quality/quantity. 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 50117972 ↗InjuryJul 31, 2026Failure to Osseointegrate
The clinician reports the implant was inserted on (b)(6) 2026 in ADA 30. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III and previous bone augmentation. The device was forwarded to the manufacturer. At the event the patient experienced: Infection, Peri-implantitis, Mobility, Swelling, Bleeding, Abscess and Inflammation. No further patient complications were reported.
Patient problems: Abscess; Fibrosis; Hemorrhage/Blood Loss/Bleeding; Inflammation; Swelling/ Edema; Unspecified Infection
MAUDE report 50104030 ↗
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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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