BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSIX PLUS

    MDR report key: 4615608 · Received March 13, 2015

    Report

    Report Number
    3010626093-2015-00001
    Event Type
    Injury
    Date Received
    March 13, 2015
    Report Date
    February 12, 2015
    Manufacturer
    DATUM DENTAL LTD.
    Product Code
    NPL
    PMA / PMN Number
    K053260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ORAPHARMA INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF DATUM DENTAL LTD IN ACCORDANCE WITH EXEMPTION (B)(4) . INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY PHYSICIAN INADVERTENTLY APPLIED THE TEMPLATE INSTEAD OF THE COLLAGEN MEMBRANE. ADDITIONAL INFO HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174695 OSSIX PLUS NPL DATUM DENTAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other