Max 15868KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
Quick summary
This Keystone Dental endosseous root-form implant is a screw-like dental implant. The 30 reports mostly describe the implant failing to fuse with the surrounding jawbone, or losing that fusion after surgery, along with infection, pain, and bone loss. No deaths were reported; all 30 reports involved injuries. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI D76815868K0), received between Feb 11, 2020 and Sep 19, 2025 — classified as 30 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (26 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 Osseointegrate26
- Loss of Osseointegration4
Patient problems
- Failure of Implant12
- Inadequate Osseointegration12
- Unspecified Infection5
- Osteopenia/ Osteoporosis4
- Pain3
- Implant Pain2
- Bacterial Infection1
- High Blood Pressure/ Hypertension1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 23094769 ↗InjuryMay 9, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryApr 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21891719 ↗InjuryJan 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21223016 ↗InjuryDec 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 21038129 ↗InjuryNov 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 19568021 ↗InjuryMay 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 18, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryJun 1, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 17042138 ↗InjuryJan 3, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryAug 5, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 26, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 6, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 11, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 16, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 16, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 23, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 22, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 22, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 25, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 14, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 5, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 11, 2021Failure 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.