Stage 1 Implant SystemRecalls & reported problems across all models
Keystone Dental, Inc. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 88
- Deaths reported
- 0
- Injuries reported
- 88
- Recalls
- 0
We found 18 models of Stage 1 Implant System by Keystone Dental, Inc. in the FDA's device registry (GUDID). Together they are named in 88 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2019 and Aug 3, 2026 — classified as 88 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (57 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Stage 1 Implant System problems
Device problems
- Loss of Osseointegration57
- Failure to Osseointegrate31
Patient problems
- Failure of Implant36
- Inadequate Osseointegration36
- Osteopenia/ Osteoporosis23
- Unspecified Infection12
- Pain6
- High Blood Pressure/ Hypertension4
- Implant Pain4
- Bruxism3
Stage 1 Implant System models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Stage 1 Implant System RSR4110-2KIMPLANT, ENDOSSEOUS, ROOT-FORM17 reports
- Stage 1 Implant System RSW4810-2KIMPLANT, ENDOSSEOUS, ROOT-FORM16 reports
- Stage 1 Implant System RSR4112-2KIMPLANT, ENDOSSEOUS, ROOT-FORM13 reports
- Stage 1 Implant System RSR4110-3KIMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- Stage 1 Implant System RSR3308-2KIMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- Stage 1 Implant System RSR3312-2KIMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- Stage 1 Implant System RSR4108-2KIMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- Stage 1 Implant System RSR4808-2KIMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- Stage 1 Implant System RSR4810-2KIMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- Stage 1 Implant System RSR4810-3KIMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Stage 1 Implant System RSW4808-2KIMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Stage 1 Implant System RSR3310-3KIMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Stage 1 Implant System RSR4112-3KIMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Stage 1 Implant System RSR4812-2KIMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Stage 1 Implant System RSW4812-2KIMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Stage 1 Implant System RSR3310-2KIMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- Stage 1 Implant System RSW5508-2KIMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- Stage 1 Implant System RSW5510-2KIMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent Stage 1 Implant System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 3, 2026Loss of Osseointegration
InjuryNov 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjurySep 10, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 23017204 ↗InjurySep 10, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 23017149 ↗InjurySep 10, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 23017128 ↗InjurySep 10, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 23017124 ↗InjurySep 10, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23016099 ↗InjurySep 9, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 23008533 ↗InjurySep 9, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 23008136 ↗InjuryJun 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMay 30, 2025Loss of Osseointegration; Loss of Osseointegration
Other Keystone Dental, Inc. products
All Keystone Dental, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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