Stage 1 Implant System RSR4110-2KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
All models of Stage 1 Implant System (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI D768RSR41102K0), received between Dec 6, 2019 and Sep 10, 2025 — classified as 17 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (10 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 Osseointegrate10
- Loss of Osseointegration7
Patient problems
- Inadequate Osseointegration7
- Osteopenia/ Osteoporosis7
- Failure of Implant6
- Unspecified Infection4
- High Blood Pressure/ Hypertension1
- Implant Pain1
- Pain1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryAug 11, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 17513611 ↗InjuryJun 22, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 17183470 ↗InjuryMay 15, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 25, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 21, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 15079419 ↗InjuryApr 15, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 22, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension
MAUDE report 13581932 ↗InjuryApr 1, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryMar 18, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 11, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 21, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 23, 2020Loss of Osseointegration; Loss of Osseointegration
InjuryMar 25, 2020Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 9879226 ↗InjuryDec 30, 2019Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 6, 2019Failure to Osseointegrate; Failure to Osseointegrate
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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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