Tri-Nex Implant System IA-LH-43-13Recalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
All models of Tri-Nex Implant System (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI D768IALH43130), received between Sep 18, 2020 and Oct 26, 2022 — classified as 5 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 18, 2026.
Most reported problems
Device problems
- Loss of Osseointegration3
- Failure to Osseointegrate2
Patient problems
- Osteopenia/ Osteoporosis2
- Pain2
- Bacterial Infection1
- Failure of Implant1
- Osteolysis1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryOct 26, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryJan 19, 2022Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Osteopenia/ Osteoporosis; Pain; Unspecified Infection
MAUDE report 13289651 ↗InjurySep 21, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 21, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 18, 2020Loss of Osseointegration; Loss of Osseointegration
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- 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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