Prima Implant System 15619KRecalls & reported problems

Keystone Dental, Inc. · Implant · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Keystone Prima dental implant has 248 reports on file, with no deaths and 248 injuries. Most describe implants that failed to bond with the jawbone, and patients mention implant failure, infection and low bone density. No recalls name this device, and reports fell to 1 in the latest year from 99 in the year before.

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: 248
Deaths reported: 0
Injuries reported: 248
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 248 adverse event reports that list this exact device (DI D76815619K0), received between Dec 10, 2019 and Nov 19, 2025 — classified as 248 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (193 reports).

7 other recalls cover devices cleared under the same FDA submission (K051614, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Osseointegrate193
Loss of Osseointegration53
Fracture2

Patient problems

Inadequate Osseointegration149
Failure of Implant74
Osteopenia/ Osteoporosis29
Unspecified Infection27
High Blood Pressure/ Hypertension10
Implant Pain7
Pain7
Bruxism3

Recent adverse event reports

The 25 most recent of 248 reports, in the reporter's own words as published by the FDA.

InjuryNov 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 23594735 ↗
InjurySep 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 23037777 ↗
InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bruxism; Inadequate Osseointegration
MAUDE report 23002952 ↗
InjurySep 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22984012 ↗
InjurySep 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22952984 ↗
InjurySep 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22946092 ↗
InjuryAug 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22911805 ↗
InjuryAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22897951 ↗
InjuryAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22897802 ↗
InjuryAug 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22814209 ↗
InjuryAug 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22814208 ↗
InjuryAug 14, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 22808559 ↗
InjuryAug 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22794699 ↗
InjuryAug 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22794612 ↗
InjuryAug 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22794403 ↗
InjuryAug 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22794231 ↗
InjuryAug 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22794059 ↗
InjuryAug 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22727025 ↗
InjuryAug 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22726901 ↗
InjuryAug 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22726777 ↗
InjuryAug 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22726650 ↗
InjuryAug 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22726556 ↗
InjuryAug 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22726307 ↗
InjuryAug 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22726264 ↗
InjuryAug 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22726167 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051614, K072768. One submission often covers many models, so check the product and lot details in each record.

Z-2162-2018 · May 1, 2018 · Terminated
Prima 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-1179-2018 · Oct 16, 2017 · Terminated
STAGE-1 RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
Z-0727-2018 · Aug 25, 2017 · Terminated
Stage-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
Z-0608-2018 · Jun 20, 2017 · Terminated
Multi-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 · Terminated
Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
Z-0299-2017 · Sep 15, 2016 · Terminated
Keystone 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 · Terminated
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.

Device details

UDI-DI	`D76815619K0`
Brand	Prima Implant System
Model	15619K
Company	Keystone Dental, Inc.
Product code	DZE · IMPLANT, ENDOSSEOUS, ROOT-FORM
Class	Class 2
FDA submission	K051614, K072768
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 1, 2025

Device type (GMDN): Screw endosteal dental implant, two-piece

A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

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All IMPLANT, ENDOSSEOUS, ROOT-FORM devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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