Prima Implant System 15629KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
Quick summary
This Keystone Dental Prima Implant is a root-form dental implant placed into the jawbone. The 75 reports mostly describe the implant failing to bond with the surrounding bone, or losing that bond after surgery, along with pain and infection. There are 75 injuries and no deaths. No recalls name this device, and reports have been fairly steady, with 4 in the last 12 months versus 6 in the previous 12.
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
- 75
- Deaths reported
- 0
- Injuries reported
- 75
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI D76815629K0), received between Nov 19, 2019 and May 6, 2026 — classified as 75 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (61 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 Osseointegrate61
- Loss of Osseointegration14
Patient problems
- Inadequate Osseointegration27
- Failure of Implant22
- Osteopenia/ Osteoporosis16
- Pain10
- Unspecified Infection8
- Implant Pain4
- Osteolysis4
- Bruxism2
Recent adverse event reports
The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2026Loss of Osseointegration
InjuryNov 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 21445858 ↗InjuryNov 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 20745596 ↗InjuryNov 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 19, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Bruxism; Implant Pain; Inadequate Osseointegration
MAUDE report 19148768 ↗InjuryJan 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 2, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 18057049 ↗InjuryOct 16, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 17942898 ↗InjurySep 5, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 17682487 ↗InjurySep 5, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 17682477 ↗InjurySep 5, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 17682467 ↗InjuryJun 26, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 13, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 25, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 17007233 ↗InjuryMay 5, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryMay 1, 2023Failure to Osseointegrate; Failure to Osseointegrate
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.