Prima Implant System 15434KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
Quick summary
This Keystone Dental Prima Implant System 15434K is a root-form endosseous dental implant used as a tooth replacement. The 34 reports describe the implant failing to bond with the surrounding bone, or losing that bond after surgery, along with bone thinning conditions and implant pain. There are no deaths, 34 injuries, and no recalls name this device. Reports fell from 6 in the prior 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
- 34
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI D76815434K0), received between Feb 3, 2020 and Sep 2, 2025 — classified as 34 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (21 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 Osseointegrate21
- Loss of Osseointegration13
Patient problems
- Inadequate Osseointegration17
- Osteopenia/ Osteoporosis12
- Failure of Implant7
- High Blood Pressure/ Hypertension4
- Implant Pain3
- Bacterial Infection2
- Bruxism1
- Osteolysis1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21573862 ↗InjuryFeb 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21409859 ↗InjuryDec 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 16, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJan 11, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 18491550 ↗InjuryNov 1, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 20, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryAug 4, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 17458060 ↗InjuryMay 2, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 1, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 28, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 16836221 ↗InjuryApr 28, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 16784003 ↗InjuryFeb 15, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bacterial Infection; Bruxism; Osteolysis
MAUDE report 15633942 ↗InjuryAug 25, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bacterial Infection; High Blood Pressure/ Hypertension; Implant Pain
MAUDE report 15298064 ↗InjuryJul 27, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 21, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 21, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 4, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryNov 1, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryOct 15, 2021Loss of Osseointegration; Loss of Osseointegration
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.