Genesis ACTIVE GA21015Recalls & reported problems
Keystone Dental, Inc. · Genesis Active Conical Implant, Ø5.5x8.5mm · Class 2 · Implant
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI D768GA210150), received between Jan 10, 2024 and Jul 10, 2025 — classified as 23 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (22 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 Osseointegrate22
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration23
- Implant Pain7
- Osteopenia/ Osteoporosis7
- High Blood Pressure/ Hypertension2
- Bruxism1
- Foreign Body Reaction1
- Unspecified Infection1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryJul 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 22469555 ↗InjuryJun 18, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMay 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21967471 ↗InjuryMay 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 21941648 ↗InjuryApr 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Foreign Body Reaction; Implant Pain; Inadequate Osseointegration
MAUDE report 21928606 ↗InjuryApr 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 21927675 ↗InjuryJan 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 21246250 ↗InjuryNov 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20745595 ↗InjuryOct 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20544682 ↗InjurySep 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20157629 ↗InjurySep 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20157620 ↗InjuryJul 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19818926 ↗InjuryJun 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 9, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bruxism; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19277528 ↗InjuryMar 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 18485351 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.