Tri-Nex Implant SystemRecalls & reported problems across all models
Keystone Dental, Inc. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 69
- Deaths reported
- 0
- Injuries reported
- 69
- Recalls
- 0
We found 18 models of Tri-Nex Implant System by Keystone Dental, Inc. in the FDA's device registry (GUDID). Together they are named in 69 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2019 and Nov 11, 2025 — classified as 69 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (41 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Tri-Nex Implant System problems
Device problems
- Loss of Osseointegration41
- Failure to Osseointegrate27
- Material Disintegration1
Patient problems
- Failure of Implant21
- Osteopenia/ Osteoporosis20
- Unspecified Infection15
- Inadequate Osseointegration14
- Pain11
- Osteolysis7
- Bacterial Infection5
- High Blood Pressure/ Hypertension5
Tri-Nex Implant System models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Tri-Nex Implant System TRI-MAX8-9IMPLANT, ENDOSSEOUS, ROOT-FORM10 reports
- Tri-Nex Implant System TRI-MAX7-11IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Tri-Nex Implant System TRI-MAX7-9IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Tri-Nex Implant System TRI-MAX8-11IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Tri-Nex Implant System IA-LH-43-10IMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- Tri-Nex Implant System IA-LH-43-13IMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- Tri-Nex Implant System IA-LH-43-11.5IMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- Tri-Nex Implant System IA-LH-35-8IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Tri-Nex Implant System IA-LH-50-10IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Tri-Nex Implant System TRI-MAX7-7IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Tri-Nex Implant System TRI-MAX8-7IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Tri-Nex Implant System TRI-MAX9-9IMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Tri-Nex Implant System IA-LH-35-10IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Tri-Nex Implant System IA-LH-35-13IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Tri-Nex Implant System TRI-MAX9-11IMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Tri-Nex Implant System IA-LH-35-11.5IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- Tri-Nex Implant System IA-LH-43-16IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- Tri-Nex Implant System IA-LH-50-8IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent Tri-Nex Implant System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryNov 11, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration; Unspecified Infection
MAUDE report 23524630 ↗InjuryOct 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 23413613 ↗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 ↗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 ↗InjuryFeb 13, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 21, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 20751596 ↗InjuryJul 25, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 17390048 ↗InjuryJun 15, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Unspecified Infection
MAUDE report 17136246 ↗InjuryMay 26, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryNov 21, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryOct 26, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryOct 26, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryOct 18, 2022Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Bacterial Infection; Bruxism; Osteolysis
MAUDE report 15627520 ↗
Other Keystone Dental, Inc. products
All Keystone Dental, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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