Genesis Implant System G21152Recalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
Quick summary
This Keystone Dental Genesis endosseous implant is a root-form dental implant. The 29 reports describe the implant failing to bond with the surrounding bone, or losing that bond after surgery, along with pain and infection. There are no deaths and 29 injuries. No recalls name this device, and no reports were filed in the past 12 months.
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
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI D768G211520), received between Dec 20, 2019 and Jan 28, 2025 — classified as 29 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (22 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate22
- Loss of Osseointegration7
Patient problems
- Inadequate Osseointegration8
- Pain8
- Implant Pain7
- Osteopenia/ Osteoporosis6
- Failure of Implant5
- Unspecified Infection4
- Bacterial Infection1
- High Blood Pressure/ Hypertension1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 21254405 ↗InjuryDec 11, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJul 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19452018 ↗InjuryApr 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19215723 ↗InjuryFeb 27, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 18790068 ↗InjuryAug 17, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 17565051 ↗InjuryJul 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 17248731 ↗InjuryNov 15, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 2, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Implant Pain
MAUDE report 15715612 ↗InjuryJul 20, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 28, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 15, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
MAUDE report 13765282 ↗InjuryNov 11, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 25, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 25, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 16, 2021Loss of Osseointegration; Loss of Osseointegration
InjurySep 1, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryJul 13, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryMay 25, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 2, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 30, 2020Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 14, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 4, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2020Failure to Osseointegrate; Failure to Osseointegrate
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.