Genesis ACTIVE GA21012Recalls & reported problems
Keystone Dental, Inc. · Genesis Active Conical Implant, Ø4.5x11.5mm · Class 2 · Implant
Quick summary
This Keystone Genesis Active dental implant is a root-form implant placed in the jaw to support dental restoration. The 26 reports mostly describe implants that did not bond to the bone, with mentions of bone loss, pain and infection. There are 26 reports naming its identifier, with no deaths and 26 injuries. No recalls name this device, with 0 reports in the most recent 12 months compared with 12 in the prior 12-month period.
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
- 26
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI D768GA210120), received between Dec 19, 2023 and Sep 9, 2025 — classified as 26 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (26 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 Osseointegrate26
Patient problems
- Inadequate Osseointegration26
- Osteopenia/ Osteoporosis7
- Implant Pain5
- Unspecified Infection3
- High Blood Pressure/ Hypertension2
- Bruxism1
- Sinus Perforation1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 23003536 ↗InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 23002943 ↗InjuryAug 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22737434 ↗InjuryJul 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Sinus Perforation
MAUDE report 22161169 ↗InjuryMay 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21989460 ↗InjuryApr 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20537907 ↗InjuryOct 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Implant Pain; Inadequate Osseointegration
MAUDE report 20140230 ↗InjuryJul 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 19497248 ↗InjuryMay 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19397315 ↗InjuryMay 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bruxism; High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 19248123 ↗InjuryMay 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19237653 ↗InjuryMay 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19236670 ↗InjuryMar 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- 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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.