Genesis ACTIVE GA21016Recalls & reported problems
Keystone Dental, Inc. · Genesis Active Conical Implant, Ø5.5x10.0mm · Class 2 · Implant
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI D768GA210160), received between Jan 12, 2024 and Jun 17, 2025 — classified as 20 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (19 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 Osseointegrate19
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration20
- Implant Pain5
- Unspecified Infection3
- Osteopenia/ Osteoporosis2
- High Blood Pressure/ Hypertension1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22237325 ↗InjuryJun 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 22099691 ↗InjuryMay 21, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22064693 ↗InjuryMay 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 21989344 ↗InjuryFeb 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 21284581 ↗InjuryJan 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 20821143 ↗InjuryNov 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 20495675 ↗InjurySep 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 19839223 ↗InjuryJun 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 19270980 ↗InjuryMay 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 18507200 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.