Prima Implant System 15711KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
All models of Prima Implant System (58)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Keystone Dental Prima Implant System is a root-form endosseous dental implant used as an artificial tooth root. The 37 adverse event reports mostly describe the implant failing to fuse with the surrounding jawbone, or losing that bond after surgery, along with bone loss around the implant and pain. No deaths were reported. There are no recalls naming this device, and no reports were filed in the past 12 months, compared with 7 in the prior12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI D76815711K0), received between Feb 3, 2020 and Sep 15, 2026 — classified as 38 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (25 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate25
- Loss of Osseointegration13
Patient problems
- Inadequate Osseointegration16
- Osteopenia/ Osteoporosis14
- Failure of Implant8
- Implant Pain6
- Pain4
- Bacterial Infection2
- High Blood Pressure/ Hypertension2
- Osteolysis2
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Loss of Osseointegration
InjuryAug 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22784488 ↗InjuryJul 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22413154 ↗InjuryJul 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22330202 ↗InjuryApr 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 21859333 ↗InjuryFeb 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19512848 ↗InjuryJun 3, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19447100 ↗InjuryApr 9, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19075322 ↗InjuryNov 15, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 18140907 ↗InjurySep 6, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 17694476 ↗InjuryMay 2, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryMar 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bacterial Infection; Implant Pain; Osteopenia/ Osteoporosis
MAUDE report 16375275 ↗InjuryDec 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 4, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 6, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryMar 24, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 28, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 5, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryOct 25, 2021Failure 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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