Prima Implant System 15635KRecalls & reported problems

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

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This Keystone Dental Prima Implant System 15635K is a root-form endosseous dental implant. The 56 reports mostly describe the implant failing to fuse with the surrounding bone or losing that fusion later, along with pain and bone loss around the site. Fifty-five reports involve injuries and none involve deaths. 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: 56
Deaths reported: 0
Injuries reported: 55
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI D76815635K0), received between Feb 14, 2020 and Aug 18, 2026 — classified as 55 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (46 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Failure to Osseointegrate46
Loss of Osseointegration10

Patient problems

Inadequate Osseointegration37
Failure of Implant15
Osteolysis5
Pain5
Implant Pain3
Osteopenia/ Osteoporosis3
Bacterial Infection1
High Blood Pressure/ Hypertension1

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

OtherAug 18, 2026Loss of Osseointegration
Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50293346 ↗
InjuryJul 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 22469319 ↗
InjuryMay 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 21988251 ↗
InjuryMay 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 21967252 ↗
InjuryFeb 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 21334876 ↗
InjuryJan 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 21069714 ↗
InjuryNov 1, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20591152 ↗
InjuryOct 18, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 20486722 ↗
InjuryOct 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 20369778 ↗
InjuryJul 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 19805180 ↗
InjuryMay 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 19314226 ↗
InjuryMay 13, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 19300352 ↗
InjuryMar 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 18886083 ↗
InjuryFeb 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 18740019 ↗
InjuryFeb 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 18739914 ↗
InjuryDec 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 18377152 ↗
InjuryNov 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 18149474 ↗
InjuryNov 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 18067301 ↗
InjurySep 26, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 17818604 ↗
InjurySep 22, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 17798049 ↗
InjuryAug 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 17451578 ↗
InjuryJul 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 17372536 ↗
InjuryJun 20, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 17165687 ↗
InjuryJun 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 17165496 ↗
InjuryJun 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration
MAUDE report 17142907 ↗

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	`D76815635K0`
Brand	Prima Implant System
Model	15635K
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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Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
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STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
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STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BL
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25,298 reports
Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
23,448 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
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22,320 reports
STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BL
Institut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM
22,267 reports

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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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