BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENEX

    MDR report key: 4213217 · Received October 1, 2014

    Report

    Report Number
    9617083-2014-00036
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    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

    SUSPECTED ROOT CAUSE: THE SURGEON SPECIALIZES IN TUMOUR RELATED ORTHOPAEDIC SURGERY. THE PATIENT HAD A HIGH VOLUME OF GENEX IMPLANTED AND ANOTHER PRODUCT ON TOP. IN ADDITION TO THIS A STRUCTURAL ALLOGRAFT (CORTICAL BONE) WAS IMPLANTED IN PATIENTS 4 AND 5. THE ALLOGRAFT WAS IMPLANTED FIRST AND GENEX WAS PLACED ON TOP. FINDINGS: ON DISCUSSION WITH THE SURGEON, THE GENEX APPEARED TO BE MIGRATED OUT OF THE VOID AND PRODUCING LARGE VOLUMES OF FLUID. THE PATIENT UNDERWENT REVISION SURGERY AND HAD THE GENEX REMOVED. BIOCOMPOSITES NOTED THAT THE VOID BEING FILLED WITH GENEX WAS NOT A CONTAINED AREA ND DUE TO THE NATURE OF GENEX, MIGRATION MAY OCCUR. THE INSTRUCTIONS FOR USE (IFU) WERE CONSULTED AND THE DOCUMENT REVISION AT THAT TIME DID NOT MAKE REFERENCE TO USING IN A CONTAINED SITE ONLY. THE SURGEON STATED THAT MIGRATION SHOULD BE ALLOWED IN SUCH LESIONS AND IT SHOULD BE EXPECTED AS IT IS OFTEN DIFFICULT TO BE LEFT WITH A CONTAINED VOID WHEN DEALING WITH VOIDS CAUSED BY TUMOURS, AND THOUGHT THAT THIS FACTOR SHOULD BE ADDED TOT HE IFU. CONCLUSION: THE SURGEON PLANNED OT PUBLISH HIS PAPER SOON, ALTHOUGH WOULD AMEND HIS CONCLUSION. THE MAIN OUTCOME WOULD INDICATE THAT GENEX IS SAFE TO BE USED INA CONTAINED AND BLOODLESS SITE. HE ALSO INDICATED THAT MAYBE BIOCOMPOSITES SHOULD INCLUDE 'USE IN A CONTAINED SITE' TO THE IFU. IFU 'WARNINGS AND PRECAUTIONS' SECTION WAS UPDATED ACCORDINGLY ON (B)(4) 2013.

    Description of Event or Problem · 1

    FINAL REPORT FOLLOWING ON FROM MDR REPORT 9617083-2013-00011, SUBMITTED TO FDA IN JUNE 2013. ROUTINE SURVEILLANCE IDENTIFIED A POSTER ABSTRACT TO BE PRESENTED AT THE 26TH EUROPEAN MUSCULOSKELETAL ONCOLOGY SOCIETY MEETING (EMOS), (B)(4) 2013; TITLED 'COMPLICATIONS ASSOCIATED WITH THE ARTIFICIAL BONE GRAFT SUBSTITUTE GENEX' (B)(4), 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
    613429 GENEX GENEX MQV BIOCOMPOSITES LTD. NOT CONFIRMED NOT CONFIRMED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention