BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDOR BIORESORBABLE MATRIX BARRIER

    MDR report key: 4383548 · Received November 25, 2014

    Report

    Report Number
    1411485-2014-00001
    Event Type
    Injury
    Date Received
    November 25, 2014
    Date of Event
    June 13, 2014
    Report Date
    November 20, 2014
    Manufacturer
    SUNSTAR AMERICAS, INC.
    Product Code
    NPK
    PMA / PMN Number
    K132325
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP BY MANUFACTURER INDICATED REPORTER'S AGREEMENT THAT CONCOMITANT USE OF BARRICADE AND BACITRACIN WITH THE MATRIX BARRIER IMPEDED SOFT TISSUE HEALING, AND THAT MOVEMENT OF BARRICAID WOULD HAVE CAUSED THE MATRIX BARRIER TO BECOME DISLODGED OR DAMAGED, ALLOWING THE BONE GRAFT MATERIAL TO MIGRATE AND DISRUPTING BONE FORMATION. (B)(4).

    Description of Event or Problem · 1

    AT A POST-OP FOLLOW UP FOR AN ORAL RIDGE PRESERVATION BONE GRAFT PROCEDURE, THE DENTIST REPORTED AS FOLLOWS: "I USED ONE OF THE P3S... CUT IN HALF, ON BACK TO BACK PROCEDURES THE SAME MORNING IN (B)(6)... IN BOTH CASES... THE PERIPHERY OF THE MEMBRANE WAS SUTURED TO THE OVERLAYING GINGIVAL MARGINS... AND NEARLY PRIMARY CLOSURE WAS ACHIEVED. THE SITES WERE COATED WITH BACITRACIN AND A BARRICAID LIGHT CURED... WAS SECURED OVER THE SURGERY SITES. <THE SITES WERE UNCOVERED> AT 4 AND 5 WEEKS RESPECTIVELY, AND... THE MATRIX BARRIER <WAS FOUND> WADDED UP IN THE MIDDLE OF THE WOUNDS, MOST... BONE GRAFT PARTICLES GONE, AND APPARENTLY NO WOUND CLOSURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766861 GUIDOR BIORESORBABLE MATRIX BARRIER BARRIER, SYNTHETIC, INTRAORAL NPK SUNSTAR AMERICAS, INC. P3 004-130012

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BACITRACIN| BARRICAID