Max 15865KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI D76815865K0), received between Apr 2, 2020 and Jul 16, 2025 — classified as 21 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (17 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 Osseointegrate17
- Loss of Osseointegration4
Patient problems
- Inadequate Osseointegration9
- Failure of Implant7
- Unspecified Infection6
- Bacterial Infection2
- Implant Pain2
- Bruxism1
- High Blood Pressure/ Hypertension1
- Osteolysis1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bruxism; Inadequate Osseointegration; Unspecified Infection
MAUDE report 22520984 ↗InjuryDec 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 21037150 ↗InjuryOct 7, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 20237367 ↗InjuryJan 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 18564101 ↗InjuryDec 12, 2023Loss of Osseointegration; Loss of Osseointegration
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 18314333 ↗InjuryFeb 16, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 15, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 15, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 4, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryJun 27, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 24, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 17, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 6, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 1, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 13, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 22, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryMar 11, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 18, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 17, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 2, 2020Failure 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.
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.