PrimaRecalls & reported problems across all models
Keystone Dental, Inc. · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 992
- Deaths reported
- 0
- Injuries reported
- 992
- Recalls
- 0
We found 19 models of Prima by Keystone Dental, Inc. in the FDA's device registry (GUDID). Together they are named in 992 adverse event reports in the FDA's MAUDE database, received between Nov 19, 2019 and Jun 1, 2026 — classified as 992 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (810 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 Prima problems
Device problems
- Failure to Osseointegrate810
- Loss of Osseointegration176
- Fracture5
- Fitting Problem1
Patient problems
- Inadequate Osseointegration552
- Failure of Implant319
- Osteopenia/ Osteoporosis172
- Implant Pain120
- High Blood Pressure/ Hypertension75
- Unspecified Infection57
- Pain42
- Osteolysis19
Prima models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Prima 15736KIMPLANT, ENDOSSEOUS, ROOT-FORM151 reports
- Prima 15741KIMPLANT, ENDOSSEOUS, ROOT-FORM111 reports
- Prima 15737KIMPLANT, ENDOSSEOUS, ROOT-FORM87 reports
- Prima 15732KIMPLANT, ENDOSSEOUS, ROOT-FORM86 reports
- Prima 15731KIMPLANT, ENDOSSEOUS, ROOT-FORM76 reports
- Prima 15740KIMPLANT, ENDOSSEOUS, ROOT-FORM74 reports
- Prima 15738KIMPLANT, ENDOSSEOUS, ROOT-FORM70 reports
- Prima 15733KIMPLANT, ENDOSSEOUS, ROOT-FORM55 reports
- Prima 15735KIMPLANT, ENDOSSEOUS, ROOT-FORM53 reports
- Prima 15742KIMPLANT, ENDOSSEOUS, ROOT-FORM53 reports
- Prima 15730KIMPLANT, ENDOSSEOUS, ROOT-FORM45 reports
- Prima 15745KIMPLANT, ENDOSSEOUS, ROOT-FORM42 reports
- Prima 15746KIMPLANT, ENDOSSEOUS, ROOT-FORM23 reports
- Prima 15743KIMPLANT, ENDOSSEOUS, ROOT-FORM19 reports
- Prima 15739KIMPLANT, ENDOSSEOUS, ROOT-FORM17 reports
- Prima 15747KIMPLANT, ENDOSSEOUS, ROOT-FORM13 reports
- Prima 15734KIMPLANT, ENDOSSEOUS, ROOT-FORM8 reports
- Prima 15744KIMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- Prima 15748KIMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
Recent Prima adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 1, 2026Loss of Osseointegration
InjuryApr 19, 2026Loss of Osseointegration
InjuryApr 13, 2026Loss of Osseointegration
InjuryApr 9, 2026Loss of Osseointegration
InjuryMar 9, 2026Loss of Osseointegration
InjuryDec 8, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Bruxism; Inadequate Osseointegration
MAUDE report 23741453 ↗InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22937948 ↗InjurySep 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22937428 ↗InjurySep 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22937288 ↗InjuryAug 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22914332 ↗InjuryAug 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22914197 ↗
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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