Prima Implant System 15709KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
Quick summary
This Prima dental implant has 231 adverse event reports, all of them injuries, and no deaths. The reports mostly describe the implant failing to bond with the jawbone, which leaves it loose and can bring pain and infection. No recalls name this device. Reports fell from 23 in the previous 12 months to 1 in the most recent 12 months.
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
- 231
- Deaths reported
- 0
- Injuries reported
- 231
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 231 adverse event reports that list this exact device (DI D76815709K0), received between Nov 14, 2019 and Apr 19, 2026 — classified as 231 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (185 reports).
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 Osseointegrate185
- Loss of Osseointegration44
- Adverse Event Without Identified Device or Use Problem1
- Defective Component1
- Failure to Disconnect1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Inadequate Osseointegration90
- Failure of Implant81
- Osteopenia/ Osteoporosis42
- Implant Pain28
- Pain25
- Unspecified Infection24
- High Blood Pressure/ Hypertension11
- Osteolysis7
Recent adverse event reports
The 25 most recent of 231 reports, in the reporter's own words as published by the FDA.
InjuryApr 19, 2026Loss of Osseointegration
InjurySep 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23026207 ↗InjurySep 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 5, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22720310 ↗InjuryAug 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Foreign Body Reaction; Implant Pain; Inadequate Osseointegration
MAUDE report 22720255 ↗InjuryJul 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 23, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22579185 ↗InjuryJun 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 22109189 ↗InjuryMay 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22052944 ↗InjuryMay 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 21959654 ↗InjuryApr 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 21867293 ↗InjuryMar 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 21709726 ↗InjuryMar 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 21630555 ↗InjuryFeb 18, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 13, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 21378460 ↗InjuryJan 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 21161840 ↗InjuryDec 6, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryOct 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.