Prima Implant System 15432KRecalls & 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
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI D76815432K0), received between Mar 25, 2020 and Aug 22, 2024 — classified as 14 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (12 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. 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 Osseointegrate12
- Loss of Osseointegration2
Patient problems
- Inadequate Osseointegration5
- Failure of Implant4
- Osteolysis3
- Osteopenia/ Osteoporosis3
- Bacterial Infection2
- Bruxism1
- High Blood Pressure/ Hypertension1
- Pain1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryAug 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20032269 ↗InjuryFeb 13, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 15, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 17, 2022Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Bruxism; High Blood Pressure/ Hypertension; Osteolysis
MAUDE report 15616910 ↗InjurySep 26, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 15489518 ↗InjuryAug 17, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 17, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 30, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 28, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 7, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryJan 19, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 2, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 25, 2020Failure 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
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- 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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