Prima 15739KRecalls & reported problems
Keystone Dental, Inc. · Prima Plus Implant · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI D76815739K0), received between Feb 3, 2020 and Oct 23, 2024 — classified as 17 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (12 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 Osseointegrate12
- Loss of Osseointegration5
Patient problems
- Failure of Implant8
- Inadequate Osseointegration7
- Osteopenia/ Osteoporosis3
- Foreign Body Reaction1
- High Blood Pressure/ Hypertension1
- Implant Pain1
- Pain1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryOct 23, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryOct 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 27, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19031484 ↗InjurySep 12, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 17731123 ↗InjuryDec 19, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Foreign Body Reaction; Implant Pain; Osteopenia/ Osteoporosis
MAUDE report 16010217 ↗InjuryNov 17, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inadequate Osseointegration
MAUDE report 15815368 ↗InjuryJul 25, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 20, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 26, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 20, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 10, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 10, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2020Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 3, 2020Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 3, 2020Loss of Osseointegration; Loss of Osseointegration
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
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
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- 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 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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