Neodent 140.944Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · GM HELIX ACQUA IMPLANT · Class 2 · Implant
Quick summary
This Neodent GM Helix Acqua implant is placed in the jawbone. The reports mostly describe implants that did not bond with the bone, with some also mentioning pain, infection or bleeding. FDA records list 5,318 reports, no deaths, 5,318 injuries and no malfunction reports. There is 1 closed recall, which began in October 2021 and concerned implants labeled with the wrong length, which could damage nearby nerves or bone if the wrong implant was installed.
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
- 5,373
- Deaths reported
- 0
- Injuries reported
- 5,373
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5,373 adverse event reports that list this exact device (DI 07899878024897), received between Aug 29, 2018 and Sep 28, 2026 — classified as 5,373 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (4,132 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Oct 11, 2021Terminated
3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.
Z-0203-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Failure to Osseointegrate4,132
- Loss of Osseointegration970
- Adverse Event Without Identified Device or Use Problem212
- Difficult to Insert38
- Fracture38
- Separation Failure5
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions2,773
- Fibrosis1,484
- Pain1,226
- Unspecified Infection846
- Inflammation377
- Hemorrhage/Blood Loss/Bleeding312
- Swelling/ Edema259
- Tissue Damage181
Recent adverse event reports
The 25 most recent of 5,373 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922991 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50922737 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain; Swelling/ Edema
MAUDE report 50922734 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922717 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922709 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50922556 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50922555 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922347 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain; Swelling/ Edema
MAUDE report 50922161 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922143 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50922139 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Unspecified Infection
MAUDE report 50922138 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918782 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918772 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50827692 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50827670 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50827461 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50823913 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 50808227 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808220 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 50808202 ↗InjurySep 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 12. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III and fair oral hygiene. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis, Pain, Mobility and Bleeding. No further patient complications were reported.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 50808199 ↗InjurySep 17, 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. Patient presented with bone type IV and fair oral hygiene. No product was returned to the manufacturer. At the event the patient experienced: Fistula. No further patient complications were reported.
Patient problems: Fistula
MAUDE report 50808161 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808144 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808135 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.