Prima 15731KRecalls & reported problems
Keystone Dental, Inc. · Prima Plus Implant · Class 2 · Implant
Quick summary
The Prima Plus Implant is a Keystone Dental root-form endosseous dental implant used as a tooth replacement anchor. The 76 reports mostly describe the implant failing to fuse with the surrounding bone or losing that bond after fusing, with patients reporting pain, infection, and low bone density. All reports describe injuries; no deaths were reported. No recalls name this device. Reports in the last 12 months (0) are down sharply from 9 in the prior 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
- 76
- Deaths reported
- 0
- Injuries reported
- 76
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI D76815731K0), received between Nov 19, 2019 and Aug 13, 2025 — classified as 76 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (63 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 Osseointegrate63
- Loss of Osseointegration12
- Fitting Problem1
Patient problems
- Inadequate Osseointegration32
- Failure of Implant23
- Osteopenia/ Osteoporosis19
- High Blood Pressure/ Hypertension7
- Pain7
- Unspecified Infection7
- Implant Pain4
- Bacterial Infection1
Recent adverse event reports
The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22506115 ↗InjuryJul 14, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 22494638 ↗InjuryMay 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 16, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMay 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 14, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 21152605 ↗InjuryOct 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20079680 ↗InjuryJul 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 16, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryJun 26, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Unspecified Infection
MAUDE report 19615074 ↗InjuryDec 28, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 18409000 ↗InjuryNov 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 27, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 18023517 ↗InjuryOct 10, 2023Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 17906286 ↗InjurySep 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 26, 2023Fitting Problem; Fitting Problem
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Implant Pain; Inadequate Osseointegration
MAUDE report 17818290 ↗InjuryJun 5, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 17062859 ↗InjuryMay 12, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 11, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Foreign Body Reaction; Inadequate Osseointegration
MAUDE report 16718062 ↗
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.