Neodent 109.956Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · GM HELIX IMPLANT · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Neodent GM Helix dental implant is placed in the jawbone. Most of its 1,094 reports describe the implant failing to bond with the bone, and some mention pain or infection. The reports include no deaths, and reports rose to 317 in the last 12 months from 232 in the previous 12 months. 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
- 1,103
- Deaths reported
- 0
- Injuries reported
- 1,103
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,103 adverse event reports that list this exact device (DI 07899878024279), received between Feb 26, 2019 and Sep 28, 2026 — classified as 1,103 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (794 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 Osseointegrate794
- Loss of Osseointegration139
- Adverse Event Without Identified Device or Use Problem132
- Difficult to Insert33
- Separation Failure3
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions594
- Pain267
- Fibrosis247
- Unspecified Infection210
- Inflammation92
- Swelling/ Edema67
- Hemorrhage/Blood Loss/Bleeding55
- Fistula30
Recent adverse event reports
The 25 most recent of 1,103 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inflammation; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50922743 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inflammation; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50918770 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50826743 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807997 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762331 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762320 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762280 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761825 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761754 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761750 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761739 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761487 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761486 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761452 ↗InjurySep 10, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720576 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720564 ↗InjurySep 10, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718837 ↗InjurySep 8, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2025 in ADA 24. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type IV and inadequate bone quality/quantity. No product was returned to the manufacturer. At the event the patient experienced: Pain. No further patient complications were reported.
Patient problems: Pain
MAUDE report 50673889 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50655548 ↗InjuryAug 27, 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. 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 50482072 ↗InjuryAug 27, 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. 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 50482070 ↗InjuryAug 24, 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. 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 50417979 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50417279 ↗InjuryAug 17, 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. 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 50285975 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in the patient's mouth. 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 50285888 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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