Neodent 109.946Recalls & 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 4,251 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 bleeding. No recalls name this device. Reports rose from 924 in the 12 months before that to 1,315 in the most recent 12 months.
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
- 4,315
- Deaths reported
- 0
- Injuries reported
- 4,315
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4,315 adverse event reports that list this exact device (DI 07899878024170), received between Dec 3, 2018 and Sep 28, 2026 — classified as 4,315 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (3,517 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 Osseointegrate3,517
- Loss of Osseointegration543
- Adverse Event Without Identified Device or Use Problem184
- Difficult to Insert44
- Fracture28
- Separation Failure11
Patient problems
- No Clinical Signs, Symptoms or Conditions2,464
- Fibrosis983
- Pain974
- Unspecified Infection647
- Inflammation274
- Hemorrhage/Blood Loss/Bleeding250
- Swelling/ Edema225
- Fistula150
Recent adverse event reports
The 25 most recent of 4,315 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923001 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922789 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922771 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50922728 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922715 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation; Pain
MAUDE report 50922642 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation; Pain
MAUDE report 50922641 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922634 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50922596 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50922584 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922522 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922356 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922073 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918781 ↗InjurySep 18, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827582 ↗InjurySep 18, 2026Difficult to Insert; Separation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827475 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Hyperresponsive to stimuli
MAUDE report 50827356 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827319 ↗InjurySep 18, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824288 ↗InjurySep 18, 2026Difficult to Insert; Separation Failure
The clinician reports that the day the implant was placed in ADA 7, failure occurred upon insertion. Details of surgery: Primary stability not achieved, Implant surface not completely covered with bone, Ridge augmentation and Immediate extraction site. Patient presented with inadequate bone quality/quantity. 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 50823964 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808340 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808315 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808309 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808287 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808020 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.