BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENEX

    MDR report key: 3204681 · Received June 28, 2013

    Report

    Report Number
    9617083-2013-00011
    Event Type
    Other
    Date Received
    June 28, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    MQV
    PMA / PMN Number
    K082381
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT, AS BIOCOMPOSITES AS THE MFR ARE AWAITING ADDITIONAL CASE DETAILS. THE INFORMATION PROVIDED TO DATE IS INCONCLUSIVE. MULTIPLE PRODUCTS HAVE BEEN USED AND CLINICAL DETAILS ARE UNCLEAR. AN UPDATE TO THIS REPORT WILL BE SUBMITTED ON RECEIPT OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ROUTINE SURVEILLANCE IDENTIFIED A POSTER ABSTRACT TO BE PRESENTED AT THE 26TH EUROPEAN MUSCULOSKELETAL ONCOLOGY SOCIETY MEETING (EMOS), 29-31 MAY 2013; TITLED 'COMPLICATIONS ASSOCIATED WITH THE ARTIFICIAL BONE GRAFT SUBSTITUTE GENEX' (POSTER REF P15:106), WHICH REPORTS, INTER ALIA, 'REVISION SURGERY DUE TO SEVERE SKIN DAMAGE'. THE POSTER SUGGESTS THE DAMAGE IS CAUSED BY GENEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295349 GENEX GENEX MQV BIOCOMPOSITES LTD. NOT CONFIRMED NOT CONFIRMED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention