Prima Implant System 15422KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Keystone Dental Prima Implant is a root-form endosseous dental implant used as an anchor in the jawbone. The 29 adverse event reports mostly describe the implant failing to fuse with the surrounding bone or losing that bond after it formed, along with reports of bone thinning and infection; all 29 involve injuries and no deaths are reported. No recalls name this device. Reports fell from 5 in the earlier 12-month period to none in the past year.
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
- 29
- Deaths reported
- 0
- Injuries reported
- 29
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI D76815422K0), received between Nov 20, 2019 and Jul 22, 2025 — classified as 29 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (18 reports).
2 other recalls cover devices cleared under the same FDA submission (K050506, K072768); they may or may not involve this specific model.
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 Osseointegrate18
- Loss of Osseointegration11
Patient problems
- Inadequate Osseointegration14
- Osteopenia/ Osteoporosis9
- Failure of Implant6
- High Blood Pressure/ Hypertension5
- Unspecified Infection4
- Bruxism1
- Implant Pain1
- Pain1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21346090 ↗InjuryJan 15, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bruxism; Inadequate Osseointegration
MAUDE report 20666791 ↗InjuryFeb 22, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJan 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 27, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryDec 27, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryDec 21, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryNov 2, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Implant Pain; Inadequate Osseointegration
MAUDE report 18057031 ↗InjuryMay 12, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryApr 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 16788154 ↗InjuryMay 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 14438711 ↗InjuryMar 30, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Unspecified Infection
MAUDE report 13957228 ↗InjuryMar 30, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Unspecified Infection
MAUDE report 13957167 ↗InjuryMar 30, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Unspecified Infection
MAUDE report 13957069 ↗InjuryMar 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 23, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 22, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryMay 17, 2021Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Osteopenia/ Osteoporosis; Pain; Unspecified Infection
MAUDE report 11838872 ↗InjuryApr 5, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 4, 2020Loss of Osseointegration; Loss of Osseointegration
InjuryJun 23, 2020Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 10184536 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K050506, K072768. One submission often covers many models, so check the product and lot details in each record.
- Z-1179-2018 · Oct 16, 2017 · TerminatedSTAGE-1 RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
- Z-0727-2018 · Aug 25, 2017 · TerminatedStage-1 RDS Indexed Abutment for RDS Stage-1 Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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