Neodent 109.976Recalls & 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 is a root-form implant placed in the jawbone. Its 3,269 reports mostly describe the implant failing to fuse with the jawbone, with patients reporting pain, scar tissue and infection. The reports include no deaths and 3,269 injuries. No recalls name this device. Reports rose in the most recent year (1,149) from the year before (806).
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
- 3,331
- Deaths reported
- 0
- Injuries reported
- 3,331
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,331 adverse event reports that list this exact device (DI 07899878024477), received between Jun 5, 2018 and Sep 30, 2026 — classified as 3,331 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,798 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 Osseointegrate2,798
- Loss of Osseointegration366
- Adverse Event Without Identified Device or Use Problem130
- Fracture23
- Difficult to Insert15
- Separation Failure7
Patient problems
- No Clinical Signs, Symptoms or Conditions2,082
- Pain618
- Fibrosis614
- Unspecified Infection523
- Swelling/ Edema124
- Inflammation122
- Fistula84
- Hemorrhage/Blood Loss/Bleeding79
Recent adverse event reports
The 25 most recent of 3,331 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. 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 50950388 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922958 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922814 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50922654 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding; Inflammation; Unspecified Infection
MAUDE report 50922643 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922481 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema
MAUDE report 50922459 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922430 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922343 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922339 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922334 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50922326 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50922184 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Swelling/ Edema
MAUDE report 50922160 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827704 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827605 ↗InjurySep 18, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in FDI 35. 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 50827407 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827406 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827405 ↗InjurySep 18, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in FDI 17. On 2026 (b)(6), non-osseointegration was verified. Patient presented with bone type III. No product was returned to the manufacturer. At the event the patient experienced: Infection. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50827327 ↗InjurySep 18, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826974 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826934 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Fibrosis; Swelling/ Edema
MAUDE report 50826830 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808339 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50808311 ↗
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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.