Prima Implant System 15417KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
Quick summary
This Keystone Prima dental implant has 118 adverse event reports, with 118 injuries and no deaths. Most describe the implant failing to bond with the jawbone. Reports fell from 25 in the prior 12 months to 2 in the last 12 months. 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
- 118
- Deaths reported
- 0
- Injuries reported
- 118
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI D76815417K0), received between Dec 6, 2019 and Nov 20, 2025 — classified as 118 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (89 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 Osseointegrate89
- Loss of Osseointegration29
Patient problems
- Inadequate Osseointegration48
- Failure of Implant43
- Osteopenia/ Osteoporosis28
- Pain5
- Unspecified Infection5
- Implant Pain4
- High Blood Pressure/ Hypertension3
- Osteolysis3
Recent adverse event reports
The 25 most recent of 118 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 23604214 ↗InjuryNov 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjurySep 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 22284954 ↗InjuryJun 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22135131 ↗InjuryMay 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21867881 ↗InjuryApr 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 21687227 ↗InjuryMar 14, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 21, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21420191 ↗InjuryFeb 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21159043 ↗
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.