Tri-Nex Implant System TRI-MAX8-9Recalls & 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
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI D768TRIMAX890), received between Dec 13, 2019 and Mar 3, 2025 — classified as 10 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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
- Failure to Osseointegrate5
- Loss of Osseointegration4
- Material Disintegration1
Patient problems
- Pain5
- Failure of Implant2
- Inadequate Osseointegration2
- Osteopenia/ Osteoporosis2
- Unspecified Infection2
- High Blood Pressure/ Hypertension1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryMar 3, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 13, 2025Material Disintegration; Material Disintegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21378384 ↗InjuryMar 18, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 22, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 9, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 18, 2021Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Osteopenia/ Osteoporosis; Pain; Unspecified Infection
MAUDE report 12024278 ↗InjuryJan 3, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 3, 2020Loss of Osseointegration; Loss of Osseointegration
InjuryDec 30, 2019Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 13, 2019Failure to Osseointegrate; Failure to Osseointegrate
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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