Genesis ACTIVE GA21011Recalls & reported problems
Keystone Dental, Inc. · Genesis Active Conical Implant, Ø4.5x10.0mm · Class 2 · Implant
Quick summary
This Keystone Dental Genesis ACTIVE GA21011 is a root-form endosseous (dental) implant, 4.5mm x 10.0mm. The 30 reports mostly describe the implant failing to fuse with the surrounding bone, so it does not become anchored and support a tooth. All30 reports are injuries, with no deaths. Patients also mentioned low bone density, infection, grinding of teeth and implant pain. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI D768GA210110), received between Jan 16, 2024 and Sep 9, 2025 — classified as 30 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (29 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 Osseointegrate29
- Loss of Osseointegration1
Patient problems
- Inadequate Osseointegration30
- Osteopenia/ Osteoporosis7
- Unspecified Infection5
- Bruxism4
- Implant Pain3
- High Blood Pressure/ Hypertension2
Recent adverse event reports
The 25 most recent of 30 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 23002938 ↗InjuryAug 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 22797843 ↗InjuryAug 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 21631428 ↗InjuryFeb 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bruxism; Inadequate Osseointegration
MAUDE report 21425671 ↗InjuryFeb 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bruxism; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21041178 ↗InjurySep 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 11, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20193191 ↗InjurySep 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 20065380 ↗InjuryAug 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 19749905 ↗InjuryJun 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19568638 ↗InjuryJun 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19404254 ↗InjuryMay 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19403877 ↗InjuryMay 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19403864 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.