Prima Implant System 15430KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI D76815430K0), received between Feb 11, 2020 and Aug 11, 2025 — classified as 23 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (16 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 Osseointegrate16
- Loss of Osseointegration6
- Fracture1
Patient problems
- Inadequate Osseointegration13
- Failure of Implant5
- Osteopenia/ Osteoporosis5
- Implant Pain3
- Osteolysis2
- Pain2
- Unspecified Infection2
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 22773250 ↗InjuryJun 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21158972 ↗InjuryJan 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 2, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 17451569 ↗InjuryJul 10, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 17287609 ↗InjuryMay 2, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 16853126 ↗InjuryMay 2, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 1, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 16843796 ↗InjuryFeb 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 15, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 2, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 20, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 28, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryDec 30, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 10, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 4, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryAug 4, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryApr 23, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 14, 2020Fracture; Fracture
InjuryFeb 11, 2020Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Osteopenia/ Osteoporosis; Pain; Unspecified Infection
MAUDE report 9694179 ↗
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
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
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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.