Prima 15730KRecalls & reported problems
Keystone Dental, Inc. · Prima Plus Implant · Class 2 · Implant
Quick summary
This Keystone Dental Prima Plus Implant is a root-form endosseous dental implant placed into the jawbone. The 46 reports mostly describe the implant failing to fuse with the surrounding bone, or losing that fusion after it had formed, along with a couple of cases where the implant itself broke; patients also reported jawbone thinning and pain. There are 46 injuries and no deaths. No recalls name this device. Reports dropped sharply, from 11 in the earlier 12 months to 1 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
- 45
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI D76815730K0), received between Nov 19, 2019 and Aug 25, 2025 — classified as 45 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (42 reports).
5 other recalls cover devices cleared under the same FDA submission (K051614); 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 Osseointegration2
- Fracture1
Patient problems
- Inadequate Osseointegration27
- Failure of Implant16
- Osteopenia/ Osteoporosis10
- Implant Pain5
- High Blood Pressure/ Hypertension3
- Foreign Body Reaction1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 22051757 ↗InjuryMay 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 22051588 ↗InjuryMay 14, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22021103 ↗InjuryApr 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21936505 ↗InjuryApr 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20727094 ↗InjuryNov 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20375439 ↗InjurySep 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20236434 ↗InjuryJun 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 19613636 ↗InjuryMar 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 18989863 ↗InjuryMar 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 18932597 ↗InjurySep 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Foreign Body Reaction; Inadequate Osseointegration
MAUDE report 17151986 ↗InjuryMay 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 16940382 ↗InjuryFeb 17, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 16400943 ↗InjuryFeb 10, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 7, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 24, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 15475792 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K051614. One submission often covers many models, so check the product and lot details in each record.
- Z-2162-2018 · May 1, 2018 · TerminatedPrima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single
- Z-0608-2018 · Jun 20, 2017 · TerminatedMulti-Unit Abutment Angled, 17, 4mm Cuff 4.1/4.5mm TiLobe Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of
- Z-1818-2017 · Mar 9, 2017 · TerminatedKeystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
- Z-0299-2017 · Sep 15, 2016 · TerminatedKeystone Dental PrimaConnex Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles a
- Z-0973-2013 · Mar 11, 2013 · TerminatedPrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
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.