BEUDAMED
    FDA Adverse Event Summary report: N

    BONE WAX

    MDR report key: 4201982 · Received September 30, 2014

    Report

    Report Number
    4201982
    Date Received
    September 30, 2014
    Date of Event
    February 12, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ETHICON, INC.
    Product Code
    MTJ
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING RHIZOTOMY PROCEDURE, SURGEON TRIED TO PLACE BONE WAX AND IT WOULD NOT STAY IN PLACE. IT MIGRATED TO ADJACENT TISSUE. PATIENT DEVELOPED AN ABSCESS AND HAD TO HAVE REDO SURGERY FOR DRAINAGE OF ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609633 BONE WAX WAX,BONE MTJ ETHICON, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR NO OTHER THERAPIES