Tri-Nex Implant System TRI-MAX7-9Recalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
All models of Tri-Nex Implant System (18)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI D768TRIMAX790), received between Dec 30, 2019 and Jul 7, 2025 — classified as 7 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (5 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. 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
- Loss of Osseointegration5
- Failure to Osseointegrate2
Patient problems
- Osteopenia/ Osteoporosis5
- Inadequate Osseointegration3
- High Blood Pressure/ Hypertension1
- Implant Pain1
- Osteolysis1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJul 7, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22411007 ↗InjuryMar 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21506455 ↗InjuryFeb 13, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryAug 19, 2022Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: High Blood Pressure/ Hypertension; Osteolysis
MAUDE report 15260010 ↗InjuryApr 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Osteopenia/ Osteoporosis; Pain; Unspecified Infection
MAUDE report 14062283 ↗InjuryDec 30, 2019Loss of Osseointegration; Loss of Osseointegration
InjuryDec 30, 2019Failure to Osseointegrate; Failure to Osseointegrate
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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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