MaxRecalls & reported problems across all models
Keystone Dental, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 141
- Deaths reported
- 0
- Injuries reported
- 141
- Recalls
- 0
We found 9 models of Max by Keystone Dental, Inc. in the FDA's device registry (GUDID). Together they are named in 141 adverse event reports in the FDA's MAUDE database, received between Dec 30, 2019 and Sep 19, 2025 — classified as 141 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (115 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 Max problems
Device problems
- Failure to Osseointegrate115
- Loss of Osseointegration26
Patient problems
- Inadequate Osseointegration79
- Osteopenia/ Osteoporosis35
- Failure of Implant31
- Unspecified Infection21
- Implant Pain14
- Pain12
- Bacterial Infection4
- High Blood Pressure/ Hypertension4
Max models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Max 15868KIMPLANT, ENDOSSEOUS, ROOT-FORM30 reports
- Max 15865KIMPLANT, ENDOSSEOUS, ROOT-FORM21 reports
- Max 15872KIMPLANT, ENDOSSEOUS, ROOT-FORM17 reports
- Max 15867KIMPLANT, ENDOSSEOUS, ROOT-FORM16 reports
- Max 15864KIMPLANT, ENDOSSEOUS, ROOT-FORM15 reports
- Max 15869KIMPLANT, ENDOSSEOUS, ROOT-FORM14 reports
- Max 15866KIMPLANT, ENDOSSEOUS, ROOT-FORM10 reports
- Max 15870KIMPLANT, ENDOSSEOUS, ROOT-FORM10 reports
- Max 15871KIMPLANT, ENDOSSEOUS, ROOT-FORM8 reports
Recent Max adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: High Blood Pressure/ Hypertension; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 23094769 ↗InjurySep 9, 2025Loss of Osseointegration; Loss of Osseointegration
InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 23003026 ↗InjuryJul 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22676137 ↗InjuryJul 16, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Bruxism; Inadequate Osseointegration; Unspecified Infection
MAUDE report 22521879 ↗InjuryJul 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bruxism; Inadequate Osseointegration; Unspecified Infection
MAUDE report 22520984 ↗InjuryJul 9, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 22420570 ↗InjuryJun 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 9, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryApr 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21891719 ↗InjuryMar 10, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21561456 ↗InjuryMar 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 5, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21529156 ↗
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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