Prima 15733KRecalls & reported problems
Keystone Dental, Inc. · Prima Plus Implant · Class 2 · Implant
All models of Prima (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Keystone Dental Prima Plus implant is a root-form endosseous implant used to anchor a replacement tooth in the jawbone. The 55 reports mostly describe the implant failing to fuse with the surrounding bone or losing that bond after it formed, along with a couple of cases where the implant itself fractured; all55 were reported as injuries, with no deaths. There are no recalls naming this device. Reporting dropped noticeably, from 10 in the previous 12 months to none in the past year.
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
- 55
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI D76815733K0), received between Jan 3, 2020 and Aug 6, 2025 — classified as 55 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (41 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate41
- Loss of Osseointegration12
- Fracture2
Patient problems
- Inadequate Osseointegration26
- Failure of Implant21
- Implant Pain8
- Osteopenia/ Osteoporosis8
- High Blood Pressure/ Hypertension5
- Osteolysis3
- Unspecified Infection3
- Pain1
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Implant Pain; Inadequate Osseointegration
MAUDE report 22731157 ↗InjuryMay 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22088242 ↗InjuryMay 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 22059607 ↗InjuryMay 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 22059595 ↗InjuryMar 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 5, 2025Fracture; Fracture
InjuryMar 5, 2025Fracture; Fracture
InjuryJan 9, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryDec 2, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 20400492 ↗InjuryJul 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 19827268 ↗InjuryMay 9, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 19281077 ↗InjuryApr 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 9, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 18104451 ↗InjuryOct 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Implant Pain; Inadequate Osseointegration
MAUDE report 17864830 ↗InjurySep 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 12, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryMar 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 14, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 16539408 ↗InjuryNov 7, 2022Failure 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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