Neodent 140.986Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · GM HELIX ACQUA IMPLANT · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Neodent GM Helix Acqua dental implant has 798 adverse event reports, all describing injuries, and no deaths. Most describe the implant failing to bond with the jawbone or losing that bond later, and some mention pain, scar tissue and infection. No recalls name this device. Reports rose from 148 in the previous 12 months to 233 in the most recent 12 months.
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
- 803
- Deaths reported
- 0
- Injuries reported
- 803
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 803 adverse event reports that list this exact device (DI 07899878025313), received between Feb 7, 2019 and Sep 28, 2026 — classified as 803 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (582 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 Osseointegrate582
- Loss of Osseointegration159
- Adverse Event Without Identified Device or Use Problem61
- Fracture2
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions418
- Pain246
- Fibrosis192
- Unspecified Infection145
- Hemorrhage/Blood Loss/Bleeding54
- Swelling/ Edema35
- Tissue Damage34
- Inflammation32
Recent adverse event reports
The 25 most recent of 803 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 50922902 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Pain
MAUDE report 50922658 ↗InjurySep 28, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 13. Details of surgery: Primary stability not achieved, Implant surface not completely covered with bone and Immediate extraction site. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Pain and Bleeding. No further patient complications were reported.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 50918840 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50827879 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50827261 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50807941 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Fistula; Pain
MAUDE report 50762371 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Fistula; Pain
MAUDE report 50762369 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50762368 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Fistula; Pain
MAUDE report 50762367 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Fistula; Unspecified Infection
MAUDE report 50739644 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50655695 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50655694 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50655478 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653052 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50653051 ↗InjuryAug 31, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50530277 ↗InjuryAug 31, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50530262 ↗InjuryAug 31, 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. 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 50529828 ↗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 50482164 ↗InjuryAug 24, 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 and Implant surface not completely covered with bone. On (b)(6)2026, loss of osseointegration was verified. Patient presented with fair oral hygiene and inadequate bone quality/quantity. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis, Pain, Mobility and Bleeding. No further patient complications were reported.
Patient problems: Fibrosis; Hemorrhage/Blood Loss/Bleeding; Pain; Unspecified Infection
MAUDE report 50417803 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Pain; Unspecified Infection
MAUDE report 50417625 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50417526 ↗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. At the event the patient experienced: Inflammation. No further patient complications were reported.
Patient problems: Inflammation
MAUDE report 50417451 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50417020 ↗
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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 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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