Prima Implant System 15413KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
Quick summary
This Keystone Dental Prima dental implant has 94 reports, all describing injuries, and no deaths. Most reports describe the implant failing to bond with the jawbone, and some mention bone thinning and infection. Reports fell from 13 in the prior 12 months to 3 in the latest 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
- 94
- Deaths reported
- 0
- Injuries reported
- 94
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI D76815413K0), received between Nov 20, 2019 and Apr 19, 2026 — classified as 94 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (57 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 Osseointegrate57
- Loss of Osseointegration36
- Adverse Event Without Identified Device or Use Problem1
- Defective Component1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Failure of Implant40
- Inadequate Osseointegration36
- Osteopenia/ Osteoporosis21
- Osteolysis5
- Pain4
- Unspecified Infection4
- Bacterial Infection2
- High Blood Pressure/ Hypertension2
Recent adverse event reports
The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.
InjuryApr 19, 2026Loss of Osseointegration
InjuryApr 19, 2026Loss of Osseointegration
InjuryApr 19, 2026Loss of Osseointegration
InjuryJul 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 22, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 9, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJun 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 22126134 ↗InjuryJun 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22124644 ↗InjuryMay 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 14, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21357693 ↗InjuryFeb 10, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21348741 ↗InjuryFeb 22, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryOct 20, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 17976703 ↗InjuryAug 17, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 3, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 17451893 ↗InjuryJul 21, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 17371712 ↗InjuryMay 8, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 8, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 28, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 16835093 ↗InjuryApr 26, 2023Failure 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.