Neodent 109.987Recalls & reported problems
JJGC Indústria e Comércio de Materiais Dentários S/A. · GM Helix Implant, Titanium, 4.0X18 mm · Class 2 · Implant
Quick summary
This Neodent GM Helix dental implant is placed in the mouth. Its 483 adverse event reports mostly describe the implant failing to bond with the bone, with many also mentioning infection and pain. There are 483 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
- 493
- Deaths reported
- 0
- Injuries reported
- 493
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 493 adverse event reports that list this exact device (DI 07899878024583), received between Jul 8, 2019 and Sep 28, 2026 — classified as 493 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (353 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 Osseointegrate353
- Loss of Osseointegration65
- Adverse Event Without Identified Device or Use Problem59
- Difficult to Insert11
- Fracture3
- Separation Failure2
Patient problems
- No Clinical Signs, Symptoms or Conditions252
- Unspecified Infection152
- Pain132
- Fibrosis112
- Swelling/ Edema33
- Inflammation17
- Hemorrhage/Blood Loss/Bleeding14
- Fistula6
Recent adverse event reports
The 25 most recent of 493 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Patient problems: Fibrosis; Fistula; Hemorrhage/Blood Loss/Bleeding; Hyperresponsive to stimuli; Pain
MAUDE report 50922488 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50922063 ↗InjurySep 18, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50827342 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Pain; Unspecified Infection
MAUDE report 50826837 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50826731 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50826697 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50761598 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720813 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50656295 ↗InjuryAug 27, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2024 in FDI 21. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type III. 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 50482065 ↗InjuryAug 17, 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. 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 50285556 ↗InjuryAug 17, 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. At the event the patient experienced: Infection and Fistula. No further patient complications were reported.
Patient problems: Fistula; Unspecified Infection
MAUDE report 50284974 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted on (b)(6)2026 in the patient's mouth. On (b)(6)2026, non-osseointegration was verified. 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 50284965 ↗InjuryAug 17, 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. No product was returned to the manufacturer. At the event the patient experienced: Swelling. No further patient complications were reported.
Patient problems: Swelling/ Edema
MAUDE report 50284585 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in FDI 16. Details of surgery: Implant surface not completely covered with bone. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type III. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis, Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50200158 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in FDI 46. Details of surgery: Implant surface not completely covered with bone. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type III. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis, Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50200157 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in FDI 36. Details of surgery: Implant surface not completely covered with bone. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type III. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis, Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50200041 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in FDI 43. On (b)(6) 2026, loss of 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 50200000 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 15. Details of surgery: Implant surface not completely covered with bone. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III and fair oral hygiene. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Unspecified Infection
MAUDE report 50199987 ↗InjuryAug 10, 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. At the event the patient experienced: Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain
MAUDE report 50199940 ↗InjuryAug 3, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2025 in FDI 18. Details of surgery: Implant surface not completely covered with bone. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type III. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis, Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50121577 ↗InjuryAug 3, 2026Failure to Osseointegrate
Patient problems: Pain; Unspecified Infection
MAUDE report 50121214 ↗InjuryAug 3, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6)2026 in FDI 27. 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 50121090 ↗InjuryJul 31, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in the patient's mouth. On (b)(6) 2026, non-osseointegration was verified. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50103898 ↗InjuryJul 31, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 41. Details of surgery: Primary stability not achieved and Immediate extraction site. 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: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50103866 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.