BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUOSS

    MDR report key: 2591877 · Received May 18, 2012

    Report

    Report Number
    2249852-2012-00001
    Event Type
    Other
    Date Received
    May 18, 2012
    Date of Event
    June 9, 2010
    Report Date
    March 10, 2012
    Manufacturer
    COLLAGEN MATRIX, INC.
    Product Code
    NPM
    PMA / PMN Number
    K043034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS NO SIGNIFICANT BONE FILL/INGROWTH AFTER 15 MONTHS POST-IMPLANTATION OF BONE GRAFT MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUOSS ANORGANIC BONE MINERAL NPM COLLAGEN MATRIX, INC. BMC2510 BMCU07G5

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention