Restore Implant System RS3813KRecalls & 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
- 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 D768RS3813K0), received between Jul 2, 2020 and Feb 20, 2025 — 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
- Fracture1
Patient problems
- Inadequate Osseointegration8
- Bruxism4
- Failure of Implant4
- High Blood Pressure/ Hypertension2
- Osteopenia/ Osteoporosis1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 20, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Bruxism; Inadequate Osseointegration
MAUDE report 21190558 ↗InjuryJan 20, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Bruxism; Inadequate Osseointegration
MAUDE report 21190515 ↗InjuryNov 6, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 6, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Bruxism; Inadequate Osseointegration
MAUDE report 20623106 ↗InjuryJul 2, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 19654332 ↗InjuryJun 27, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Bruxism; High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 19627062 ↗InjuryJun 27, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 4, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 4, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 4, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 19, 2021Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration
InjuryJul 2, 2020Failure 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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