Prima Implant System 15429KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
Quick summary
The Prima Implant System 15429K is a Keystone Dental root-form dental implant used as a tooth replacement anchor in the jaw. The 37 reports mostly describe the implant failing to bond with the surrounding bone, or losing that bond after surgery, along with pain, infection, and bone-density conditions in the patient. All 37 reports describe injuries, with no deaths mentioned. No recalls name this device.
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
- 36
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI D76815429K0), received between Nov 20, 2019 and Aug 4, 2025 — classified as 36 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (24 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 Osseointegrate24
- Loss of Osseointegration12
Patient problems
- Failure of Implant17
- Osteopenia/ Osteoporosis11
- Inadequate Osseointegration9
- Unspecified Infection4
- Implant Pain2
- Bruxism1
- Osteolysis1
- Pain1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22698664 ↗InjuryMar 12, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 21586982 ↗InjuryFeb 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 21412606 ↗InjuryJan 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 21060707 ↗InjuryAug 14, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJun 14, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19539184 ↗InjuryJun 10, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 18757594 ↗InjuryApr 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bruxism; Inadequate Osseointegration
MAUDE report 16784047 ↗InjuryAug 12, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 6, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 6, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 2, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 1, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryAug 4, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryJun 23, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryJun 8, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 5, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 15, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 30, 2020Loss of Osseointegration; Loss of Osseointegration
InjurySep 11, 2020Loss of Osseointegration; Loss of Osseointegration
InjuryJul 9, 2020Loss of Osseointegration; Loss of Osseointegration
InjuryJul 9, 2020Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 10250953 ↗InjuryJul 6, 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
- 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.