Neodent 140.978Recalls & 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 dental implant is a root-form implant placed in the jawbone. Its 3,191 reports mostly describe the implant failing to fuse with the jawbone, with patients reporting pain, infection and scar tissue. The reports include no deaths and 3,191 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
- 3,229
- Deaths reported
- 0
- Injuries reported
- 3,229
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,229 adverse event reports that list this exact device (DI 07899878025238), received between Apr 24, 2018 and Sep 28, 2026 — classified as 3,229 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,675 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 Osseointegrate2,675
- Loss of Osseointegration393
- Adverse Event Without Identified Device or Use Problem118
- Fracture29
- Difficult to Insert24
- Separation Failure6
Patient problems
- No Clinical Signs, Symptoms or Conditions1,767
- Pain800
- Fibrosis782
- Unspecified Infection557
- Inflammation187
- Hemorrhage/Blood Loss/Bleeding178
- Swelling/ Edema161
- Fistula95
Recent adverse event reports
The 25 most recent of 3,229 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50923002 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Swelling/ Edema
MAUDE report 50922729 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922692 ↗InjurySep 28, 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. No product was returned to the manufacturer. At the event the patient experienced: Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain
MAUDE report 50922678 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922671 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50922624 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922581 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50827852 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827663 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation
MAUDE report 50827590 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827534 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827441 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 50827247 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 50827242 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808353 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50808230 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50808107 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50808105 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807970 ↗InjurySep 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 1. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis, Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50806488 ↗InjurySep 16, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in ADA 25. Details of surgery: Primary stability not achieved. On (B)(6) 2026 non-osseointegration was verified. Patient presented with bone type III. No product was returned to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792250 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50761757 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761694 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761672 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761655 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.