Prima Implant SystemRecalls & reported problems across all models
Keystone Dental, Inc. · 58 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4,227
- Deaths reported
- 0
- Injuries reported
- 4,226
- Recalls
- 0
We found 58 models of Prima Implant System by Keystone Dental, Inc. in the FDA's device registry (GUDID). Together they are named in 4,227 adverse event reports in the FDA's MAUDE database, received between Nov 14, 2019 and Sep 15, 2026 — classified as 4,226 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (3,347 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 Implant System problems
Device problems
- Failure to Osseointegrate3,347
- Loss of Osseointegration863
- Fracture9
- Defective Component3
- Failure to Disconnect3
- Loosening of Implant Not Related to Bone-Ingrowth3
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Inadequate Osseointegration2,111
- Failure of Implant1,547
- Osteopenia/ Osteoporosis734
- Unspecified Infection397
- Implant Pain354
- Pain209
- High Blood Pressure/ Hypertension132
- Osteolysis105
Prima Implant System models
58 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Prima Implant System 15617KIMPLANT, ENDOSSEOUS, ROOT-FORM379 reports
- Prima Implant System 15618KIMPLANT, ENDOSSEOUS, ROOT-FORM328 reports
- Prima Implant System 15613KIMPLANT, ENDOSSEOUS, ROOT-FORM287 reports
- Prima Implant System 15621KIMPLANT, ENDOSSEOUS, ROOT-FORM270 reports
- Prima Implant System 15619KIMPLANT, ENDOSSEOUS, ROOT-FORM248 reports
- Prima Implant System 15709KIMPLANT, ENDOSSEOUS, ROOT-FORM231 reports
- Prima Implant System 15614KIMPLANT, ENDOSSEOUS, ROOT-FORM216 reports
- Prima Implant System 15622KIMPLANT, ENDOSSEOUS, ROOT-FORM181 reports
- Prima Implant System 15615KIMPLANT, ENDOSSEOUS, ROOT-FORM145 reports
- Prima Implant System 15713KIMPLANT, ENDOSSEOUS, ROOT-FORM131 reports
- Prima Implant System 15706KIMPLANT, ENDOSSEOUS, ROOT-FORM129 reports
- Prima Implant System 15417KIMPLANT, ENDOSSEOUS, ROOT-FORM118 reports
- Prima Implant System 15708KIMPLANT, ENDOSSEOUS, ROOT-FORM103 reports
- Prima Implant System 15712KIMPLANT, ENDOSSEOUS, ROOT-FORM102 reports
- Prima Implant System 15413KIMPLANT, ENDOSSEOUS, ROOT-FORM94 reports
- Prima Implant System 15634KIMPLANT, ENDOSSEOUS, ROOT-FORM90 reports
- Prima Implant System 15710KIMPLANT, ENDOSSEOUS, ROOT-FORM87 reports
- Prima Implant System 15421KIMPLANT, ENDOSSEOUS, ROOT-FORM82 reports
- Prima Implant System 15629KIMPLANT, ENDOSSEOUS, ROOT-FORM75 reports
- Prima Implant System 15418KIMPLANT, ENDOSSEOUS, ROOT-FORM61 reports
- Prima Implant System 15635KIMPLANT, ENDOSSEOUS, ROOT-FORM56 reports
- Prima Implant System 15630KIMPLANT, ENDOSSEOUS, ROOT-FORM55 reports
- Prima Implant System 15620KIMPLANT, ENDOSSEOUS, ROOT-FORM49 reports
- Prima Implant System 15625KIMPLANT, ENDOSSEOUS, ROOT-FORM49 reports
- Prima Implant System 15414KIMPLANT, ENDOSSEOUS, ROOT-FORM48 reports
- Prima Implant System 15623KIMPLANT, ENDOSSEOUS, ROOT-FORM46 reports
- Prima Implant System 15419KIMPLANT, ENDOSSEOUS, ROOT-FORM40 reports
- Prima Implant System 15707KIMPLANT, ENDOSSEOUS, ROOT-FORM40 reports
- Prima Implant System 15711KIMPLANT, ENDOSSEOUS, ROOT-FORM38 reports
- Prima Implant System 15429KIMPLANT, ENDOSSEOUS, ROOT-FORM36 reports
- Prima Implant System 15434KIMPLANT, ENDOSSEOUS, ROOT-FORM34 reports
- Prima Implant System 15422KIMPLANT, ENDOSSEOUS, ROOT-FORM29 reports
- Prima Implant System 15423KIMPLANT, ENDOSSEOUS, ROOT-FORM29 reports
- Prima Implant System 15626KIMPLANT, ENDOSSEOUS, ROOT-FORM28 reports
- Prima Implant System 15415KIMPLANT, ENDOSSEOUS, ROOT-FORM27 reports
- Prima Implant System 15616KIMPLANT, ENDOSSEOUS, ROOT-FORM27 reports
- Prima Implant System 15631KIMPLANT, ENDOSSEOUS, ROOT-FORM26 reports
- Prima Implant System 15425KIMPLANT, ENDOSSEOUS, ROOT-FORM23 reports
- Prima Implant System 15430KIMPLANT, ENDOSSEOUS, ROOT-FORM23 reports
- Prima Implant System 15636KIMPLANT, ENDOSSEOUS, ROOT-FORM20 reports
- Prima Implant System 15435KIMPLANT, ENDOSSEOUS, ROOT-FORM18 reports
- Prima Implant System 15632KIMPLANT, ENDOSSEOUS, ROOT-FORM18 reports
- Prima Implant System 15627KIMPLANT, ENDOSSEOUS, ROOT-FORM16 reports
- Prima Implant System 15432KIMPLANT, ENDOSSEOUS, ROOT-FORM14 reports
- Prima Implant System 15431KIMPLANT, ENDOSSEOUS, ROOT-FORM13 reports
- Prima Implant System 15624KIMPLANT, ENDOSSEOUS, ROOT-FORM12 reports
- Prima Implant System 15436KIMPLANT, ENDOSSEOUS, ROOT-FORM10 reports
- Prima Implant System 15427KIMPLANT, ENDOSSEOUS, ROOT-FORM8 reports
- Prima Implant System 15426KIMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Prima Implant System 15437KIMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- Prima Implant System 15637KIMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- Prima Implant System 15416KIMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- Prima Implant System 15633KIMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- Prima Implant System 15400KIMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Prima Implant System 15406KIMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Prima Implant System 15424KIMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Prima Implant System 15628KIMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Prima Implant System 15433KIMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent Prima Implant System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Loss of Osseointegration
OtherAug 18, 2026Loss of Osseointegration
InjuryAug 9, 2026Loss of Osseointegration
InjuryAug 5, 2026Loss of Osseointegration
InjuryJun 16, 2026Loss of Osseointegration
InjuryJun 16, 2026Loss of Osseointegration
InjuryJun 9, 2026Loss of Osseointegration
InjuryMay 26, 2026Loss of Osseointegration
InjuryMay 6, 2026Loss of Osseointegration
InjuryApr 26, 2026Loss of Osseointegration
InjuryApr 26, 2026Loss of Osseointegration
InjuryApr 19, 2026Loss of Osseointegration
InjuryApr 19, 2026Loss of Osseointegration
InjuryApr 19, 2026Loss of Osseointegration
InjuryApr 19, 2026Loss of Osseointegration
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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