Genesis ACTIVE GA21006Recalls & reported problems
Keystone Dental, Inc. · Genesis Active Conical Implant, Ø3.8x10.0mm · Class 2 · Implant
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI D768GA210060), received between Jan 10, 2024 and Aug 5, 2025 — classified as 19 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (18 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 Osseointegrate18
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration19
- Implant Pain5
- Unspecified Infection3
- Bruxism2
- High Blood Pressure/ Hypertension2
- Osteopenia/ Osteoporosis1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 21934044 ↗InjuryFeb 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 21114808 ↗InjuryNov 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 20761583 ↗InjuryOct 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 20498964 ↗InjuryAug 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 20040727 ↗InjuryAug 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bruxism; Inadequate Osseointegration
MAUDE report 19907713 ↗InjuryAug 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bruxism; Inadequate Osseointegration
MAUDE report 19907696 ↗InjuryAug 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 19805272 ↗InjuryJun 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 19461815 ↗InjuryJun 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 19458895 ↗InjuryMay 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19403652 ↗InjuryMay 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 18510864 ↗InjuryJan 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
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- 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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.