Neodent 109.983Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · GM HELIX IMPLANT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Neodent GM Helix dental implant appears in 9,485 adverse event reports, all of them injury reports, with no deaths. The reports mostly describe implants that fail to bond with the jawbone or later lose that bond, with some mentioning infection, pain and swelling. Reports in the last 12 months number 3,289, up from 2,391 the year before. 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
- 9,702
- Deaths reported
- 0
- Injuries reported
- 9,702
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9,702 adverse event reports that list this exact device (DI 07899878024545), received between Sep 19, 2018 and Sep 30, 2026 — classified as 9,702 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (8,269 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 Osseointegrate8,269
- Loss of Osseointegration967
- Adverse Event Without Identified Device or Use Problem351
- Difficult to Insert84
- Fracture35
- Separation Failure19
Patient problems
- No Clinical Signs, Symptoms or Conditions5,536
- Unspecified Infection2,036
- Fibrosis2,016
- Pain1,946
- Inflammation529
- Swelling/ Edema459
- Hemorrhage/Blood Loss/Bleeding308
- Fistula303
Recent adverse event reports
The 25 most recent of 9,702 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950390 ↗InjurySep 30, 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. Patient presented with bone type III. 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 50950379 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950357 ↗InjurySep 30, 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. Patient presented with bone type III. 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 50950351 ↗InjurySep 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026(b)(6) in the patient's mouth. On 2026(b)(6), non-osseointegration was verified. Patient presented with bone type III. 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 50950342 ↗InjurySep 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026(b)(6) in the patient's mouth. On 2026(b)(6), 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 50950333 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain; Swelling/ Edema
MAUDE report 50923014 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50922975 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain; Unspecified Infection
MAUDE report 50922957 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50922956 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50922949 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922926 ↗InjurySep 28, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2022 in FDI 45. 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 50922857 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50922847 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50922846 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50922845 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: Abscess; Fibrosis; Unspecified Infection
MAUDE report 50922841 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922836 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922777 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922775 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922772 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922765 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922760 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922691 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain; Swelling/ Edema
MAUDE report 50922684 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- 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 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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