Neodent 140.982Recalls & 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 a root-form device placed in bone. Its 3,031 adverse event reports mostly describe implants where bone did not fuse to the implant, and some mention fractures, difficult insertion, pain, bleeding and infection. The reports include no deaths and 3,031 injuries. 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
- 3,068
- Deaths reported
- 0
- Injuries reported
- 3,068
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,068 adverse event reports that list this exact device (DI 07899878025276), received between Jan 25, 2019 and Sep 28, 2026 — classified as 3,068 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,587 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate2,587
- Loss of Osseointegration304
- Adverse Event Without Identified Device or Use Problem139
- Fracture25
- Difficult to Insert20
- Separation Failure4
Patient problems
- No Clinical Signs, Symptoms or Conditions1,731
- Pain722
- Fibrosis698
- Unspecified Infection477
- Hemorrhage/Blood Loss/Bleeding179
- Inflammation157
- Swelling/ Edema117
- Fistula87
Recent adverse event reports
The 25 most recent of 3,068 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50923013 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922919 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50922682 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50922621 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922387 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922380 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50827260 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 50827249 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50827212 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: Pain; Swelling/ Edema
MAUDE report 50808077 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 50808054 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807916 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Fistula; Pain
MAUDE report 50762418 ↗InjurySep 14, 2026Fracture
Patient problems: Fibrosis; Fistula; Inflammation; Pain
MAUDE report 50762415 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Fistula; Pain
MAUDE report 50762394 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Fistula; Pain
MAUDE report 50762372 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50762222 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762187 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50761933 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761884 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761882 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761703 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761702 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761698 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761659 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.