Genesis Implant System G21050Recalls & 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 Genesis dental implant has 119 adverse event reports, with 119 injuries and no deaths. Most describe the implant failing to bond with the jawbone. Reports fell from 13 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
- 119
- Deaths reported
- 0
- Injuries reported
- 119
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI D768G210500), received between Jan 3, 2020 and Nov 20, 2025 — classified as 119 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (108 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 Osseointegrate108
- Loss of Osseointegration10
- Deformation Due to Compressive Stress1
Patient problems
- Inadequate Osseointegration70
- Failure of Implant31
- Osteopenia/ Osteoporosis22
- High Blood Pressure/ Hypertension18
- Implant Pain17
- Pain8
- Unspecified Infection7
- Bacterial Infection2
Recent adverse event reports
The 25 most recent of 119 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22457269 ↗InjuryJun 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21917494 ↗InjuryApr 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21528226 ↗InjuryJan 20, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21191417 ↗InjuryJan 3, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21034684 ↗InjuryNov 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 20734348 ↗InjurySep 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 20180552 ↗InjuryJun 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19173429 ↗InjuryApr 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 19172850 ↗InjuryApr 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19164954 ↗InjuryApr 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19147277 ↗InjuryApr 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 19013853 ↗InjuryMar 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 18996915 ↗InjuryFeb 28, 2024Loss of Osseointegration; Loss of Osseointegration
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- 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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