Prima Implant System 15414KRecalls & 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 dental implant surgically placed in the jawbone. The 48 adverse event reports mostly describe the implant failing to fuse with the surrounding bone or losing that bond after healing, along with bone loss around the implant and implant pain; all 48 reports involve injuries and no deaths. There are no recalls naming this device. Reports in the last 12 months (2) are far fewer than the 12 in the prior 12 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
- 48
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI D76815414K0), received between Dec 30, 2019 and Aug 9, 2026 — classified as 48 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (30 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 Osseointegrate30
- Loss of Osseointegration18
Patient problems
- Inadequate Osseointegration29
- Failure of Implant14
- Osteopenia/ Osteoporosis9
- Implant Pain4
- Osteolysis3
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2026Loss of Osseointegration
InjuryNov 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 23597976 ↗InjurySep 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22967579 ↗InjuryAug 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 22126199 ↗InjuryApr 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 23, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 3, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryNov 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 28, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJan 29, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 27, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryDec 7, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 18284481 ↗InjuryOct 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 17785137 ↗InjuryAug 21, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 17587204 ↗InjuryJun 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 17145854 ↗InjuryJun 14, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 17126035 ↗InjuryMay 26, 2023Failure to Osseointegrate; Failure to Osseointegrate
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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