Neodent 109.943Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · GM HELIX IMPLANT · Class 2 · Implant
Quick summary
This Neodent GM Helix dental implant has 4,130 adverse event reports, all describing injuries and no deaths. The reports mostly describe implants that fail to fuse with the jawbone or later lose their hold, with patients mentioning 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
- 4,174
- Deaths reported
- 0
- Injuries reported
- 4,174
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4,174 adverse event reports that list this exact device (DI 07899878024149), received between Oct 28, 2018 and Sep 30, 2026 — classified as 4,174 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (3,437 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 Osseointegrate3,437
- Loss of Osseointegration514
- Adverse Event Without Identified Device or Use Problem178
- Difficult to Insert27
- Fracture27
- Separation Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions2,433
- Fibrosis929
- Pain858
- Unspecified Infection665
- Inflammation225
- Swelling/ Edema190
- Hemorrhage/Blood Loss/Bleeding180
- Fistula165
Recent adverse event reports
The 25 most recent of 4,174 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 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. Patient presented with bone type IV. 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 50950381 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950365 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922962 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922766 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922696 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain; Swelling/ Edema
MAUDE report 50922681 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain; Unspecified Infection
MAUDE report 50922421 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50922410 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50922329 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50922164 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50827869 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827817 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827607 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Hyperresponsive to stimuli; Numbness; Swelling/ Edema; Unspecified Infection
MAUDE report 50827081 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50826999 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fibrosis; Inflammation
MAUDE report 50826994 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50826939 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Fistula; Swelling/ Edema; Unspecified Infection
MAUDE report 50826938 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826936 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50826896 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation; Pain; Unspecified Infection
MAUDE report 50826895 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826890 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Pain; Unspecified Infection
MAUDE report 50826749 ↗InjurySep 18, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 20. On (b)(6) 2026, non-osseointegration was verified. 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 50824570 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 8, 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 50824412 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.