Prima Implant System 15418KRecalls & 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 used to replace missing teeth. The 61 reports mostly describe implants that fail to fuse with the surrounding bone, or that lose that fusion over time, along with pain and infection; all 61 reports involved injuries and none involved deaths. No recalls name this device. Reports fell sharply in the past 12 months, with 1 report compared with 9 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
- 61
- Deaths reported
- 0
- Injuries reported
- 61
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI D76815418K0), received between Nov 20, 2019 and Nov 19, 2025 — classified as 61 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (42 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 Osseointegrate42
- Loss of Osseointegration19
Patient problems
- Failure of Implant27
- Inadequate Osseointegration23
- Osteopenia/ Osteoporosis20
- Unspecified Infection8
- Implant Pain4
- Pain3
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 23597108 ↗InjuryJun 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22284922 ↗InjuryJun 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22126276 ↗InjuryJun 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22124751 ↗InjuryMay 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22017911 ↗InjuryApr 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21866423 ↗InjuryMar 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 21631552 ↗InjuryMar 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21158441 ↗InjuryMar 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 18879968 ↗InjuryOct 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 22, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 17182448 ↗InjuryJun 9, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 17100162 ↗InjuryMay 8, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryApr 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 27, 2022Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 15685644 ↗InjurySep 2, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRAT.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 15349932 ↗InjuryAug 1, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 15142028 ↗InjuryJul 25, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryJul 11, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 14978251 ↗InjuryJul 5, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 14919575 ↗InjuryJun 17, 2022Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 14735019 ↗InjuryApr 8, 2022Failure 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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