BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSIX PLUS 15*25

    MDR report key: 14844845 · Received June 28, 2022

    Report

    Report Number
    1222802-2022-00006
    Event Type
    Injury
    Date Received
    June 28, 2022
    Report Date
    June 28, 2022
    Manufacturer
    DATUM DENTAL LTD.
    Product Code
    NPL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    ID, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OSSIX BONE GRAFTING MATERIAL FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2043365 OSSIX PLUS 15*25 BARRIER, ANIMAL SOURCE, INTRAORAL NPL DATUM DENTAL LTD. OP150047

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention