Neodent 140.947Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · GM HELIX ACQUA IMPLANT · Class 2 · Implant
Quick summary
This Neodent GM Helix Acqua implant is placed in bone. Most of the 1,355 reports describe the implant failing to bond with the bone or losing that bond, and some mention pain, infection or scar tissue. The reports include no deaths and 1,355 injuries. 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
- 1,371
- Deaths reported
- 0
- Injuries reported
- 1,371
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,371 adverse event reports that list this exact device (DI 07899878024927), received between Oct 24, 2018 and Sep 17, 2026 — classified as 1,371 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (851 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 Osseointegrate851
- Loss of Osseointegration406
- Adverse Event Without Identified Device or Use Problem63
- Fracture42
- Difficult to Insert16
Patient problems
- No Clinical Signs, Symptoms or Conditions654
- Fibrosis344
- Pain335
- Unspecified Infection153
- Inflammation112
- Tissue Damage101
- Hyperresponsive to stimuli42
- Swelling/ Edema38
Recent adverse event reports
The 25 most recent of 1,371 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808225 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808218 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808213 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50808207 ↗InjurySep 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 15. 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 50808198 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50807883 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762460 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50761881 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761747 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50761269 ↗InjurySep 14, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in ADA 26. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758023 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50757694 ↗InjurySep 14, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2020 in ADA 26. Details of surgery: Implant surface not completely covered with bone. On (B)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50757583 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739465 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720481 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 28, failure occurred upon insertion. Details of surgery: Primary stability not achieved. 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 50718740 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50656307 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50656216 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50655671 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50655597 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653184 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50652954 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50417588 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50417582 ↗InjuryAug 24, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 3. 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 50413411 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.