Genesis Implant System G21051Recalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
All models of Genesis Implant System (22)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Keystone Dental Genesis dental implant is a tooth-root replacement placed in the jawbone. All 88 reports are injuries, mostly describing the implant failing to bond with the bone. No deaths are listed. Reports fell from 17 in the prior 12 months to 1 in the last 12 months. 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
- 88
- Deaths reported
- 0
- Injuries reported
- 88
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI D768G210510), received between Jan 3, 2020 and Nov 21, 2025 — classified as 88 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (82 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate82
- Loss of Osseointegration5
- Fracture1
Patient problems
- Inadequate Osseointegration50
- Failure of Implant27
- Osteopenia/ Osteoporosis11
- Implant Pain10
- Unspecified Infection10
- Pain7
- High Blood Pressure/ Hypertension3
- Bacterial Infection2
Recent adverse event reports
The 25 most recent of 88 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22983645 ↗InjuryAug 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 23, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22457290 ↗InjuryJul 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22438495 ↗InjuryJun 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 22284910 ↗InjuryApr 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21912693 ↗InjuryApr 18, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryApr 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 25, 2025Fracture; Fracture
InjuryFeb 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21242701 ↗InjuryJan 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Reaction
MAUDE report 20658719 ↗InjuryOct 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 20385972 ↗InjuryOct 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 25, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJul 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 19031456 ↗InjuryFeb 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 18711386 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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