Restore Implant System RS3811KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
All models of Restore Implant System (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI D768RS3811K0), received between Nov 20, 2019 and Feb 20, 2025 — classified as 14 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (6 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 Osseointegration6
- Failure to Osseointegrate5
- Fracture4
Patient problems
- Failure of Implant7
- Inadequate Osseointegration4
- Bone Fracture(s)2
- High Blood Pressure/ Hypertension2
- Bruxism1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 19, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 5, 2024Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration
IMPLANT FRACTURE.
Patient problems: Bruxism; High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 20610296 ↗InjuryJul 18, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryMay 9, 2023Fracture; Fracture
InjuryMay 9, 2023Fracture; Fracture
InjuryAug 3, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryNov 30, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 29, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryMar 16, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 7, 2021Fracture; Fracture
InjurySep 4, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 20, 2019Failure to Osseointegrate; Failure to Osseointegrate
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- 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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