KONTACT SRecalls & reported problems across all models
Biotech Dental · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 47
- Recalls
- 0
We found 13 models of KONTACT S by Biotech Dental in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Aug 16, 2023 and May 28, 2026 — classified as 47 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (44 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 KONTACT S problems
Device problems
- Failure to Osseointegrate44
- Loss of Osseointegration3
Patient problems
- Failure of Implant47
KONTACT S models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- KONTACT S K4012-36SImplant, Endosseous, Root-Form8 reports
- KONTACT S K4010-36SImplant, Endosseous, Root-Form6 reports
- KONTACT S K4508-42SImplant, Endosseous, Root-Form6 reports
- KONTACT S K4510-36SImplant, Endosseous, Root-Form5 reports
- KONTACT S K5010-42SImplant, Endosseous, Root-Form4 reports
- KONTACT S K4008-36SImplant, Endosseous, Root-Form3 reports
- KONTACT S K5008-42SImplant, Endosseous, Root-Form3 reports
- KONTACT S K5508-42SImplant, Endosseous, Root-Form3 reports
- KONTACT S K4212SImplant, Endosseous, Root-Form2 reports
- KONTACT S K4512-42SImplant, Endosseous, Root-Form2 reports
- KONTACT S K5012-42SImplant, Endosseous, Root-Form2 reports
- KONTACT S K4512-36SImplant, Endosseous, Root-Form2 reports
- KONTACT S K4510-42SImplant, Endosseous, Root-Form1 report
Recent KONTACT S adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 28, 2026Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 25319618 ↗InjuryMar 17, 2026Loss of Osseointegration
THE IMPLANT WAS MOBILE WHEN REMOVING THE COVER SCREW FOR THE FIRST TIME AT UNCOVERY.IMPLANT DID NOT INTEGRATE AND WAS REMOVED WITH REVERSE FINGER TORQUE WITH COVER SCREW STILL FULLY SEATED.
Patient problems: Failure of Implant
MAUDE report 24619958 ↗InjuryJan 7, 2026Loss of Osseointegration
THE IMPLANT FAILED DUE TO AN INFECTION THAT LED TO LOSS OF OSSEOINTEGRATION
Patient problems: Failure of Implant
MAUDE report 23994429 ↗InjuryJan 7, 2026Loss of Osseointegration
THE IMPLANT FAILED DUE TO AN INFECTION THAT LED TO LOSS OF OSSEOINTEGRATION.
Patient problems: Failure of Implant
MAUDE report 23994426 ↗InjuryDec 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20917601 ↗InjuryDec 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20916878 ↗InjuryDec 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20915076 ↗InjuryDec 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20853326 ↗InjuryNov 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20760159 ↗InjuryOct 31, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20577577 ↗InjuryOct 31, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20577571 ↗InjuryOct 31, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20577569 ↗InjuryOct 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20536062 ↗InjuryOct 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20453154 ↗InjuryOct 15, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20452706 ↗
Other Biotech Dental products
All Biotech Dental 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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