Neodent 140.953Recalls & 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 has 2,549 adverse event reports, with no deaths and 2,549 injuries. Most reports describe the implant failing to bond with the jawbone, with patients reporting pain, infection and bleeding. 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
- 2,599
- Deaths reported
- 0
- Injuries reported
- 2,599
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,599 adverse event reports that list this exact device (DI 07899878024989), received between Mar 6, 2019 and Sep 28, 2026 — classified as 2,599 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,910 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 Osseointegrate1,910
- Loss of Osseointegration350
- Adverse Event Without Identified Device or Use Problem254
- Difficult to Insert80
- Fracture8
- Separation Failure4
Patient problems
- No Clinical Signs, Symptoms or Conditions1,389
- Fibrosis649
- Pain601
- Unspecified Infection440
- Hemorrhage/Blood Loss/Bleeding174
- Inflammation159
- Swelling/ Edema118
- Fistula69
Recent adverse event reports
The 25 most recent of 2,599 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
The clinician reports that the day the implant was placed in ADA 14, 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 50922907 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50922903 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922894 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922738 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922704 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain; Swelling/ Edema
MAUDE report 50922683 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50922660 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50922656 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922606 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918852 ↗InjurySep 28, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in ADA 4. 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 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 50918839 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918838 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918759 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918756 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827792 ↗InjurySep 18, 2026Fracture
Patient problems: Fibrosis
MAUDE report 50827553 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827495 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50827209 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827135 ↗InjurySep 18, 2026Fracture
Patient problems: Fibrosis
MAUDE report 50824220 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824022 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50808216 ↗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. At the event the patient experienced: Pain. No further patient complications were reported.
Patient problems: Pain
MAUDE report 50808212 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50808084 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50808083 ↗
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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 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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