Prima Implant System 15621KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
All models of Prima Implant System (58)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Keystone Dental Prima dental implant has 270 reports, with no deaths and 270 injuries. Most describe the implant failing to bond with the jawbone or losing that bond, and some mention thin or weak bone in the patient. Reports dropped sharply over the last 12 months, to 7 from 51 the year before. 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
- 270
- Deaths reported
- 0
- Injuries reported
- 270
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 270 adverse event reports that list this exact device (DI D76815621K0), received between Nov 20, 2019 and Mar 4, 2026 — classified as 270 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (218 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate218
- Loss of Osseointegration50
- Fracture2
Patient problems
- Inadequate Osseointegration129
- Failure of Implant119
- Osteopenia/ Osteoporosis49
- Implant Pain24
- Unspecified Infection22
- Pain9
- Bruxism6
- High Blood Pressure/ Hypertension5
Recent adverse event reports
The 25 most recent of 270 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2026Loss of Osseointegration
InjuryMar 2, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Pain; Unspecified Infection
MAUDE report 24481423 ↗InjuryNov 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 20, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 23604894 ↗InjuryNov 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 25, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22884764 ↗InjuryAug 20, 2025Fracture; Fracture
InjuryAug 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22833365 ↗InjuryAug 14, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 13, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 6, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSEEOINTEGRATION.
Patient problems: High Blood Pressure/ Hypertension; Implant Pain; Inadequate Osseointegration
MAUDE report 22730880 ↗InjuryAug 6, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 22730004 ↗InjuryAug 5, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 4, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22699067 ↗InjuryAug 1, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 22688053 ↗InjuryAug 1, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22686981 ↗InjuryJul 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22643076 ↗InjuryJul 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 26, 2025Failure 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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