KONTACTRecalls & reported problems across all models
Biotech Dental · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 101
- Deaths reported
- 0
- Injuries reported
- 100
- Recalls
- 0
We found 15 models of KONTACT by Biotech Dental in the FDA's device registry (GUDID). Together they are named in 101 adverse event reports in the FDA's MAUDE database, received between Jul 10, 2023 and Sep 10, 2026 — classified as 100 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (93 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 problems
Device problems
- Failure to Osseointegrate93
- Loss of Osseointegration8
Patient problems
- Failure of Implant101
KONTACT models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- KONTACT K3610Implant, Endosseous, Root-Form17 reports
- KONTACT K3612Implant, Endosseous, Root-Form16 reports
- KONTACT K4210Implant, Endosseous, Root-Form16 reports
- KONTACT K4212Implant, Endosseous, Root-Form11 reports
- KONTACT K4810Implant, Endosseous, Root-Form9 reports
- KONTACT K3608Implant, Endosseous, Root-Form7 reports
- KONTACT K4208Implant, Endosseous, Root-Form7 reports
- KONTACT K30-10Implant, Endosseous, Root-Form4 reports
- KONTACT K3614Implant, Endosseous, Root-Form4 reports
- KONTACT K4808Implant, Endosseous, Root-Form4 reports
- KONTACT K30-12Implant, Endosseous, Root-Form2 reports
- KONTACT K3616Implant, Endosseous, Root-Form1 report
- KONTACT K4214Implant, Endosseous, Root-Form1 report
- KONTACT K4216Implant, Endosseous, Root-Form1 report
- KONTACT K4812Implant, Endosseous, Root-Form1 report
Recent KONTACT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Failure of Implant
MAUDE report 50722673 ↗InjuryJul 16, 2026Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 25845271 ↗InjuryJun 17, 2026Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 25537597 ↗InjuryApr 13, 2026Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTGRATE.
Patient problems: Failure of Implant
MAUDE report 24865013 ↗InjuryApr 13, 2026Loss of Osseointegration
IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 24863990 ↗InjuryApr 8, 2026Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 24821383 ↗InjuryFeb 12, 2026Failure to Osseointegrate
IMPLANT BECAME LOOSE AND DID NOT INTEGRATE INTO THE BONE.
Patient problems: Failure of Implant
MAUDE report 24327890 ↗InjuryFeb 12, 2026Failure to Osseointegrate
IMPLANT BECAME MOBILE AND DID NOT INTEGRATE INTO BONE.
Patient problems: Failure of Implant
MAUDE report 24327889 ↗InjuryFeb 12, 2026Failure to Osseointegrate
IMPLANT DID NOT INTEGRATE INTO BONE, PAIN AND BECAME MOBILE.
Patient problems: Failure of Implant
MAUDE report 24327888 ↗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 23994428 ↗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 23994427 ↗InjuryDec 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 23926502 ↗InjuryNov 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 23513009 ↗InjuryNov 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 23513008 ↗InjuryOct 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 23417903 ↗
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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