Genesis Implant System G21131Recalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
All models of Genesis Implant System (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Keystone Dental Genesis implant is a screw-shaped dental implant placed into bone. Its 149 reports describe the implant failing to fuse with the bone or losing that fusion, and some mention pain around the implant. The reports include 149 injuries and no deaths. Reports fell to 3 in the last 12 months from 24 in the 12 months before. 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
- 149
- Deaths reported
- 0
- Injuries reported
- 149
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 149 adverse event reports that list this exact device (DI D768G211310), received between Jan 2, 2020 and Nov 20, 2025 — classified as 149 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (113 reports).
3 other recalls cover devices cleared under the same FDA submission (K101545); they may or may not involve this specific model.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate113
- Loss of Osseointegration35
- Fracture1
Patient problems
- Inadequate Osseointegration89
- Failure of Implant43
- Osteopenia/ Osteoporosis33
- Implant Pain18
- High Blood Pressure/ Hypertension15
- Pain9
- Unspecified Infection9
- Osteolysis8
Recent adverse event reports
The 25 most recent of 149 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 23596927 ↗InjurySep 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 23026124 ↗InjurySep 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22754902 ↗InjuryJul 23, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22574542 ↗InjuryJul 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22350267 ↗InjuryJun 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 9, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 21994681 ↗InjuryApr 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21917512 ↗InjuryMar 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 21631177 ↗InjuryMar 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21528198 ↗InjuryFeb 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 21414569 ↗InjuryFeb 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21412625 ↗InjuryJan 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21093454 ↗InjuryNov 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 14, 2024Loss of Osseointegration; Loss of Osseointegration
Recalls under the same FDA submission
These recalls involve devices cleared under K101545. One submission often covers many models, so check the product and lot details in each record.
- Z-1485-2018 · Mar 13, 2018 · TerminatedGenesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
- Z-0924-2013 · Jul 5, 2011 · TerminatedGenesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or ful
- Z-0923-2013 · Jul 5, 2011 · TerminatedGenesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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