Prima Implant System 15706KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
Quick summary
This Keystone Prima dental implant is a screw placed in the jawbone to anchor a replacement tooth. All 129 reports are injuries, with no deaths; most describe the implant failing to fuse with the bone, and some mention low bone density or pain. No reports came in during the last 12 months, down from 21 in the 12 months before. No recalls name this device.
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
- 129
- Deaths reported
- 0
- Injuries reported
- 129
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI D76815706K0), received between Dec 13, 2019 and Sep 9, 2025 — classified as 129 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (93 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate93
- Loss of Osseointegration36
Patient problems
- Inadequate Osseointegration60
- Failure of Implant49
- Osteopenia/ Osteoporosis18
- Implant Pain16
- Unspecified Infection13
- Pain10
- Osteolysis6
- Bacterial Infection5
Recent adverse event reports
The 25 most recent of 129 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 22469774 ↗InjuryJun 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 30, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 20, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 22051847 ↗InjuryMay 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 5, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 3, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 24, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 21446418 ↗InjuryFeb 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21332487 ↗InjuryJan 10, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 21054899 ↗InjuryNov 20, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 20737508 ↗InjuryAug 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19733925 ↗InjuryJun 13, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19528808 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.