Prima 15737KRecalls & reported problems
Keystone Dental, Inc. · Prima Plus Implant · Class 2 · Implant
Quick summary
This Keystone Dental Prima Plus dental implant is placed in the jawbone to replace a missing tooth root. The 87 adverse event reports, all describing injuries and none reporting deaths, mostly mention implants that failed to fuse with the jawbone or lost that connection over time, sometimes with pain or infection. 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
- 87
- Deaths reported
- 0
- Injuries reported
- 87
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI D76815737K0), received between Feb 3, 2020 and Aug 11, 2025 — classified as 87 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (74 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 Osseointegrate74
- Loss of Osseointegration13
Patient problems
- Inadequate Osseointegration36
- Failure of Implant32
- Osteopenia/ Osteoporosis16
- Implant Pain11
- Unspecified Infection9
- High Blood Pressure/ Hypertension6
- Bruxism3
- Osteolysis3
Recent adverse event reports
The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 22771813 ↗InjuryJun 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22089682 ↗InjuryMay 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20642770 ↗InjuryOct 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 20, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryOct 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 18, 2024Loss of Osseointegration; Loss of Osseointegration
InjurySep 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20129697 ↗InjurySep 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 20128433 ↗InjuryAug 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20031110 ↗InjuryMay 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 27, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 18985676 ↗InjuryMar 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bruxism; Implant Pain; Inadequate Osseointegration
MAUDE report 18912564 ↗InjuryMar 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bruxism; Implant Pain; Inadequate Osseointegration
MAUDE report 18912513 ↗InjuryFeb 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 7, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 18083264 ↗InjuryOct 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 27, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bruxism; Implant Pain; Inadequate Osseointegration
MAUDE report 17211552 ↗InjuryJun 26, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryJun 23, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 17194838 ↗InjuryJun 23, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 16965653 ↗
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.