KONTACT S K5008-42SRecalls & reported problems
Biotech Dental · Implant Øexternal 5.0mm L08mm Øcore 4.2mm · Class 2 · Implant
All models of KONTACT S (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03701045273721), received between Mar 6, 2024 and Mar 17, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Loss of Osseointegration” (2 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
- Loss of Osseointegration2
- Failure to Osseointegrate1
Patient problems
- Failure of Implant3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryMar 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED DUE TO FAILURE TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 18851323 ↗
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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 13, 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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