KONTACT K4208Recalls & reported problems
Biotech Dental · Implant Ø4.2mm L08mm · Class 2 · Implant
All models of KONTACT (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03701045271024), received between Feb 16, 2024 and Feb 12, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (7 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate7
Patient problems
- Failure of Implant7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2026Failure to Osseointegrate
IMPLANT BECAME LOOSE AND DID NOT INTEGRATE INTO THE BONE.
Patient problems: Failure of Implant
MAUDE report 24327890 ↗InjuryJul 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
ACCORDING TO DR. (B)(6), THE DENTAL IMPLANT WAS PLACED ON (B)(6) 2025. THE PATIENT RETURNED FOR FOLLOW-UP ON (B)(6) 2025, AT WHICH TIME CLINICAL EXAMINATION REVEALED AN ABSCESS WITH PURULENT DISCHARGE AT THE IMPLANT SITE. INCISION AND DRAINAGE WERE PERFORMED, AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE PATIENT PRESENTED AGAIN ON (B)(6) 2025, REPORTING THAT ON THE MORNING OF (B)(6) 2025, SHE FELT THE IMPLANT BEGIN TO LOOSEN, AND BY THAT EVENING, SHE COULD NO LONGER FEEL IT IN HER MOUTH. THE PATIENT STATED THAT SHE WAS UNCERTAIN WHETHER SHE INADVERTENTLY SWALLOWED THE IMPLANT. A PERIAPICAL RADIOGRAPH CONFIRMED THE ABSENCE OF THE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 22613211 ↗InjurySep 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20130392 ↗InjuryAug 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 20090597 ↗InjuryAug 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 19910008 ↗InjuryMar 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18851396 ↗InjuryFeb 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18727522 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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