Prima 15745KRecalls & reported problems
Keystone Dental, Inc. · Prima Plus Implant · Class 2 · Implant
Quick summary
This Keystone Dental Prima Plus implant is placed in the jaw to support a dental restoration. Reports mainly describe the implant failing to fuse with the jawbone or losing that connection. There are 42 reports, including 42 injuries and no deaths; no recalls name this device. Reports fell from 7 in the previous 12 months to 0 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
- 42
- Deaths reported
- 0
- Injuries reported
- 42
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI D76815745K0), received between Dec 30, 2019 and Jun 25, 2025 — classified as 42 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (36 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 Osseointegrate36
- Loss of Osseointegration6
Patient problems
- Inadequate Osseointegration25
- Failure of Implant11
- Osteopenia/ Osteoporosis10
- Implant Pain8
- High Blood Pressure/ Hypertension6
- Bruxism1
- Foreign Body Reaction1
- Pain1
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22329683 ↗InjuryJun 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 21899672 ↗InjuryApr 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 10, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Bruxism; Inadequate Osseointegration
MAUDE report 21345964 ↗InjuryDec 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 20853808 ↗InjuryNov 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 20600065 ↗InjurySep 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 20239887 ↗InjuryJul 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19804863 ↗InjuryMay 9, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19280970 ↗InjuryApr 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 19095867 ↗InjuryApr 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 18557035 ↗InjuryJan 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 18444214 ↗InjuryDec 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 18345074 ↗InjuryNov 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 18232682 ↗InjuryNov 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 15, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Implant Pain; Inadequate Osseointegration
MAUDE report 18141655 ↗InjuryOct 30, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 18028552 ↗InjuryOct 26, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 22, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 17597552 ↗InjuryAug 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 28, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
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.