Neodent 140.980Recalls & 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 dental implant is anchored in the jawbone. Most of the 583 reports describe the implant not fusing with the bone, and many mention pain, infection and fibrosis. The reports include 583 injuries and no deaths. 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
- 580
- Deaths reported
- 0
- Injuries reported
- 580
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 580 adverse event reports that list this exact device (DI 07899878025252), received between Jul 15, 2019 and Sep 18, 2026 — classified as 580 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (465 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 Osseointegrate465
- Loss of Osseointegration76
- Adverse Event Without Identified Device or Use Problem30
- Difficult to Insert6
- Fracture3
Patient problems
- No Clinical Signs, Symptoms or Conditions334
- Pain141
- Fibrosis132
- Unspecified Infection95
- Hemorrhage/Blood Loss/Bleeding29
- Inflammation29
- Swelling/ Edema26
- Fistula22
Recent adverse event reports
The 25 most recent of 580 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50827222 ↗InjurySep 16, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 22. 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 50792251 ↗InjurySep 16, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 25. 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 50792240 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50761774 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50761695 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50761346 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739460 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50720771 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Fistula; Inflammation; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50720420 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025 (b)(6) in the patient's mouth. On 2026 (b)(6), non-osseointegration was verified. No product was returned to the manufacturer. At the event the patient experienced: Infection, Pain and Swelling. No further patient complications were reported.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50482095 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50417886 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Pain; Unspecified Infection
MAUDE report 50417682 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50417385 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50417376 ↗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 50417368 ↗InjuryAug 24, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 26. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Pain and Swelling. No further patient complications were reported.
Patient problems: Pain; Swelling/ Edema
MAUDE report 50417343 ↗InjuryAug 24, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 26. 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: Peri-implantitis and Pain. No further patient complications were reported.
Patient problems: Pain; Unspecified Infection
MAUDE report 50417181 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Pain; Unspecified Infection
MAUDE report 50417120 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50413353 ↗InjuryAug 24, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 6. On 2026-07-20, non-osseointegration was verified. Patient presented with poor oral hygiene and 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 50413326 ↗InjuryAug 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in the patient's mouth. Details of surgery: Primary stability not achieved. On (b)(6 )2026, loss of osseointegration was verified. Patient presented with poor oral hygiene and inadequate bone quality/quantity. The device was forwarded to the manufacturer. At the event the patient experienced: Infection, Peri-implantitis, Mobility, Bleeding, Fistula and Inflammation. No further patient complications were reported.
Patient problems: Fibrosis; Fistula; Hemorrhage/Blood Loss/Bleeding; Inflammation; Unspecified Infection
MAUDE report 50285817 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted on (b)(6)2026 in the patient's mouth. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. On (b)(6)2026, non-osseointegration was verified. Patient presented with inadequate bone quality/quantity. No product was returned to the manufacturer. At the event the patient experienced: Infection, Pain, Mobility and Bleeding. No further patient complications were reported.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 50285014 ↗InjuryAug 13, 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 50240161 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in the patient's mouth. Details of surgery: Implant surface not completely covered with bone. On (B)(6) 2026, non-osseointegration was verified. Patient presented with inadequate bone quality/quantity. The device was forwarded to the manufacturer. At the event the patient experienced: Infection, Pain, Mobility, Bleeding and Fistula. No further patient complications were reported.
Patient problems: Fibrosis; Fistula; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 50044812 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in the patient's mouth. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. On (B)(6) 2026, non-osseointegration was verified. Patient presented with inadequate bone quality/quantity. No product was returned to the manufacturer. At the event the patient experienced: Infection and Pain. No further patient complications were reported.
Patient problems: Pain; Unspecified Infection
MAUDE report 50044617 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
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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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