Neodent 140.943Recalls & 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 dental implant is designed to fuse with the jawbone. Its 2,734 reports mostly describe the implant failing to fuse with the bone, and some also mention fractures. The reports include 2,734 injuries and no deaths. Patient problems listed include scar tissue, pain, infection and swelling. 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
- 2,750
- Deaths reported
- 0
- Injuries reported
- 2,750
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,750 adverse event reports that list this exact device (DI 07899878024880), received between Oct 18, 2018 and Sep 28, 2026 — classified as 2,750 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,234 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 Osseointegrate2,234
- Loss of Osseointegration374
- Adverse Event Without Identified Device or Use Problem96
- Fracture28
- Difficult to Insert21
- Separation Failure3
Patient problems
- No Clinical Signs, Symptoms or Conditions1,482
- Fibrosis709
- Pain578
- Unspecified Infection353
- Inflammation142
- Swelling/ Edema133
- Hemorrhage/Blood Loss/Bleeding97
- Tissue Damage85
Recent adverse event reports
The 25 most recent of 2,750 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain; Swelling/ Edema
MAUDE report 50923011 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922976 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50922670 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827831 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824482 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fistula
MAUDE report 50808162 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation; Pain
MAUDE report 50762498 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Fistula; Pain
MAUDE report 50762384 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762264 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762255 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762254 ↗InjurySep 14, 2026Difficult to Insert
Patient problems: Fibrosis
MAUDE report 50761872 ↗InjurySep 14, 2026Difficult to Insert
The clinician reports that the day the implant was placed in ADA 21, failure occurred upon insertion. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. Patient presented with bone type IV and inadequate bone quality/quantity. The device was forwarded to the manufacturer. At the event the patient experienced: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50757590 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739720 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739712 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739613 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739392 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739391 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739388 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Fistula
MAUDE report 50739302 ↗InjurySep 11, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in the patient's mouth. On 2026 (b)(6), non-osseointegration was verified. 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 50739267 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720694 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50720428 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50720422 ↗InjurySep 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 29. 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 50718856 ↗
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- 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 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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