Prima Implant System 15423KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
Quick summary
This Keystone Dental Prima Implant System 15423K is a root-form endosseous dental implant used to replace missing teeth. The 29 reports describe implants that failed to bond with the surrounding bone or lost that bond later, along with pain and infection in some patients. All 29 reports involve injuries, and no deaths were reported. No recalls name this device. Reporting dropped from 15 in the earlier 12 months to none in the most recent 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
- 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 D76815423K0), received between Dec 13, 2019 and Jun 2, 2025 — classified as 29 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (20 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 Osseointegrate20
- Loss of Osseointegration9
Patient problems
- Inadequate Osseointegration21
- Implant Pain7
- Osteopenia/ Osteoporosis7
- Failure of Implant6
- Unspecified Infection3
- Bruxism1
- Osteolysis1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 22123972 ↗InjuryMay 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22116706 ↗InjuryMay 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 21157821 ↗InjuryJan 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 21157524 ↗InjuryJan 14, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 21152679 ↗InjuryJan 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 12, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 20666419 ↗InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20664648 ↗InjuryNov 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 20663921 ↗InjuryNov 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 20655269 ↗InjuryNov 8, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Bruxism; Implant Pain; Inadequate Osseointegration
MAUDE report 20641635 ↗InjuryNov 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20631039 ↗InjuryMar 26, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryDec 27, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryApr 27, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 24, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 16795530 ↗InjuryApr 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 16791713 ↗InjurySep 2, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 25, 2022Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 15099000 ↗InjuryAug 26, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 26, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 12, 2021Failure 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.