Prima Implant System 15708KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
Quick summary
This is a Keystone Dental Prima dental implant. Most reports describe the implant failing to osseointegrate or losing osseointegration; some patients report implant pain or infection. There are 103 adverse event reports naming this identifier, with no deaths and 103 injuries. It has no recalls. Reports fell from 14 in the previous 12 months to 1 in the last 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
- 103
- Deaths reported
- 0
- Injuries reported
- 103
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 103 adverse event reports that list this exact device (DI D76815708K0), received between Nov 19, 2019 and Apr 26, 2026 — classified as 103 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (87 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 Osseointegrate87
- Loss of Osseointegration16
Patient problems
- Inadequate Osseointegration45
- Failure of Implant43
- Osteopenia/ Osteoporosis16
- Implant Pain10
- Unspecified Infection7
- Pain6
- High Blood Pressure/ Hypertension5
- Bacterial Infection4
Recent adverse event reports
The 25 most recent of 103 reports, in the reporter's own words as published by the FDA.
InjuryApr 26, 2026Loss of Osseointegration
InjuryAug 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 14, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22804136 ↗InjuryAug 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22721389 ↗InjuryJul 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 11, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 22108994 ↗InjuryMay 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 13, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20929450 ↗InjuryDec 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20844257 ↗InjuryDec 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bruxism; High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 20844202 ↗InjuryNov 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis; Unspecified Infection
MAUDE report 20335574 ↗InjuryMay 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration
MAUDE report 19255136 ↗InjuryApr 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 19008116 ↗InjuryMar 29, 2024Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 18, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 5, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 21, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 15, 2023Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 17755837 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.