Neodent 140.976Recalls & 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 implant is a screw placed in the jawbone to hold a replacement tooth. Of its 1,773 reports, all filed as injuries, most describe the implant failing to fuse with the bone or later losing that bond. Reports also mention pain, scar-like tissue and infection. Reports rose from 399 in the prior 12 months to 538 in the latest 12 months. There are no deaths reported, and 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
- 1,804
- Deaths reported
- 0
- Injuries reported
- 1,804
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,804 adverse event reports that list this exact device (DI 07899878025214), received between Nov 26, 2018 and Sep 28, 2026 — classified as 1,804 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,516 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 Osseointegrate1,516
- Loss of Osseointegration208
- Adverse Event Without Identified Device or Use Problem64
- Fracture12
- Difficult to Insert7
- Separation Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions998
- Pain414
- Fibrosis394
- Unspecified Infection258
- Inflammation94
- Hemorrhage/Blood Loss/Bleeding78
- Tissue Damage67
- Swelling/ Edema63
Recent adverse event reports
The 25 most recent of 1,804 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 50922982 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922934 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922708 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922693 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922181 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Fibrosis; Inflammation; Unspecified Infection
MAUDE report 50827844 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Fibrosis; Inflammation; Unspecified Infection
MAUDE report 50827843 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50827634 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50808215 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50808195 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50808063 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807888 ↗InjurySep 16, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in FDI 33. On (B)(6) 2026, 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 50792230 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Fistula; Pain
MAUDE report 50762365 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762209 ↗InjurySep 14, 2026Difficult to Insert
Patient problems: Fibrosis
MAUDE report 50761876 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761650 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761266 ↗InjurySep 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 36. On (b)(6) 2026, non-osseointegration was verified. 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 50761231 ↗InjurySep 14, 2026Difficult to Insert
The clinician reports that the day the implant was placed in ADA 23, 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 50757593 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739726 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739718 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739618 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Fistula; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 50739449 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50739315 ↗
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- 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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