Neodent 140.984Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · GM HELIX ACQUA IMPLANT · Class 2 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Neodent GM Helix Acqua dental implant is a root-form implant placed in the jawbone. Its 3,149 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 3,149 injuries. There is 1 open recall, started in May 2025, over packages that may contain a different implant size than their label states.
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
- 3,202
- Deaths reported
- 0
- Injuries reported
- 3,202
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3,202 adverse event reports that list this exact device (DI 07899878025290), received between Dec 12, 2018 and Sep 28, 2026 — classified as 3,202 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,527 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- May 1, 2025Open, Classified
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Z-1862-2025 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Failure to Osseointegrate2,527
- Loss of Osseointegration484
- Adverse Event Without Identified Device or Use Problem152
- Difficult to Insert28
- Fracture16
- Separation Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions1,725
- Pain791
- Fibrosis747
- Unspecified Infection604
- Inflammation238
- Hemorrhage/Blood Loss/Bleeding186
- Swelling/ Edema162
- Fistula101
Recent adverse event reports
The 25 most recent of 3,202 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50922688 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50827885 ↗InjurySep 18, 2026Separation Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827735 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827712 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827661 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827622 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827531 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827486 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827444 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50827394 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50827385 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50827254 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824028 ↗InjurySep 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 50808363 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: Fibrosis; Hyperresponsive to stimuli; Pain
MAUDE report 50808245 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fistula
MAUDE report 50808239 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808222 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808197 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808133 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50808081 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 50808057 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808055 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808016 ↗InjurySep 15, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in FDI 35. On (B)(6) 2026, non-osseointegration was verified. Patient presented with bone type III. 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 50777424 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Fistula; Inflammation; Pain
MAUDE report 50762414 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.