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Kontour™ Sustain KRM3040Recalls & reported problems

Implant Direct Sybron Manufacturing LLC · Kontour™ Sustain Resorbable Collagen Membrane - 30mm x 40mm · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841307130567), received between Mar 8, 2021 and Mar 8, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Patient Device Interaction Problem1

Patient problems

  • Post Operative Wound Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 8, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

    IT WAS REPORTED THAT THE PRODUCT WAS USED BUT DID NOT APPEAR TO HAVE BEEN RESORBED WHICH CAUSED IRRITATION AND INFECTION. THE AREA WAS ADDITIONALLY DEBRIDED AND THE MEMBRANE WAS REPLACED.

    Patient problems: Post Operative Wound Infection

    MAUDE report 11440252 ↗

Other Barrier, Animal Source, Intraoral devices

All Barrier, Animal Source, Intraoral devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.