BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUOSS CANCELLOUS

    MDR report key: 3075021 · Received April 18, 2013

    Report

    Report Number
    2249852-2013-00002
    Event Type
    Other
    Date Received
    April 18, 2013
    Date of Event
    January 11, 2013
    Report Date
    February 25, 2013
    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

    BONE GRAFTING PROCEDURE HAD TO BE REPEATED, BECAUSE THE BONE GRAFT AREA HAD NO BONE - AREA WAS MUSHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168523 NUOSS CANCELLOUS BONE GRAFT MATERIAL NPM COLLAGEN MATRIX, INC. 509-9001, 509-9002 BMCU11H3, BMCU11K2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention