Prima Implant System 15622KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
Quick summary
This Keystone Prima dental implant is a device placed into the jawbone. Most of the 181 reports describe the implant failing to bond with the bone, and the reports include 181 injuries and no deaths. Reports from the last 12 months number 4, compared with 19 in the 12 months before. 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
- 181
- Deaths reported
- 0
- Injuries reported
- 181
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 181 adverse event reports that list this exact device (DI D76815622K0), received between Dec 30, 2019 and Jun 16, 2026 — classified as 181 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (148 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
Most reported problems
Device problems
- Failure to Osseointegrate148
- Loss of Osseointegration32
- Fracture1
Patient problems
- Failure of Implant128
- Inadequate Osseointegration62
- Osteopenia/ Osteoporosis8
- Unspecified Infection8
- High Blood Pressure/ Hypertension5
- Pain4
- Implant Pain3
- Osteolysis3
Recent adverse event reports
The 25 most recent of 181 reports, in the reporter's own words as published by the FDA.
InjuryJun 16, 2026Loss of Osseointegration
InjuryNov 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 3, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 22888820 ↗InjuryAug 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 23, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMay 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 31, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21631692 ↗InjuryFeb 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 19, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 27, 2025Fracture; Fracture
InjuryJan 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21157604 ↗InjuryNov 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 20758640 ↗InjuryNov 4, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryOct 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 20513487 ↗
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 · 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-1179-2018 · Oct 16, 2017 · TerminatedSTAGE-1 RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
- Z-0727-2018 · Aug 25, 2017 · TerminatedStage-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 · 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.