Stage 1 Implant System RSR4112-2KRecalls & 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
- 13
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI D768RSR41122K0), received between Dec 30, 2019 and Aug 3, 2026 — classified as 13 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (9 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
- Loss of Osseointegration9
- Failure to Osseointegrate4
Patient problems
- Inadequate Osseointegration8
- Failure of Implant5
- Pain1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryAug 3, 2026Loss 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
InjuryMar 31, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 31, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 24, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 24, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 24, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 7, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryDec 30, 2019Failure to Osseointegrate; Failure to Osseointegrate
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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