BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTYS HBS

    MDR report key: 3221891 · Received July 11, 2013

    Report

    Report Number
    3006761298-2013-00002
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 3, 2011
    Report Date
    July 11, 2013
    Manufacturer
    GRAFTYS
    Product Code
    MQV
    PMA / PMN Number
    K082498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING AN INSPECTION AT OUR MANUFACTURING SITE IN MARCH 2013, INSPECTOR HIGHLIGHTED A WEAKNESS IN OUR VIGILANCE PROCEDURES: WE SHOULD HAVE HAD NOTIFY TO COMPETENT AUTHORITIES SOME OF OUR COMPLAINTS. FOLLOWING THIS NON CONFORMITY, WE REVIEWED OUR VIGILANCE PROCEDURES AND REVIEWED ALL COMPLAINTS RECEIVED SO FAR (SINCE YEAR 2007). WE IDENTIFIED COMPLAINTS THAT NEEDED TO BE NOTIFIED AND WE DID. THAT EXPLAINS THE DELAY BETWEEN US BECOMING AWARE OF THE INCIDENT AND THE DATE WE NOTIFIED IT.

    Description of Event or Problem · 1

    ONE OF OUR DISTRIBUTOR (FROM (B)(6)) RELATED US THE FOLLOWING SITUATION: SURGEON TREATED WITH GRAFTYS HBS A NON INFECTED CYSTIC LESION (IN A MAXILLOFACIAL PROCEDURE). THIS SITUATION IS KNOWN IN OUR RISK ANALYSIS AS A POTENTIAL CONSEQUENCES LINKED TO THE SURGICAL TECHNIQUE USED. WE DON'T KNOW HOW MANY DEVICES SURGEON USED DURING SURGERY. FIFTEEN DAYS AFER SURGERY, AS PT DIDN'T RECOVER, SURGEON HAD TO REMOVE THE GRAFT AND HAVING THE RECOVERY OF THE WOUND. THE EVENT OCCURRED IN (B)(6). EUROPEAN COMPETENT AUTHORITY CONCERNED (B)(4) HAS BEEN NOTIFIED OF THAT CASE. AS IT HAS BEEN REPORTED, SURGEON DID NOT MANIPULATED THE DEVICE PROPERLY; THEREFORE, HE COULD NOT REACH THE EXPECTED RESULTS. HE ALSO TRIED TO COMPARE GRAFTYS HBS WITH A CONCURRENT DEVICE THAT CAN'T BE COMPARED BECAUSE THEY ARE TWO DIFFERENT PRODUCTS WITH TWO DIFFERENT EXPECTED. DISTRIBUTOR EXPLAINED TO SURGEON THE DIFFERENCE BETWEEN BOTH PRODUCTS AND THE EXPECTED RESULTS FOR EACH OF THEM. DISTRIBUTOR PROVIDED TO THE SURGEON MORE TRAINING AND LITERATURE ABOUT THE USE OF GRAFTYS HBS IN MAXILLOFACIAL PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320611 GRAFTYS HBS GRAFTYS HBS MQV GRAFTYS NOT COMMUNICATED NOT COMMUNICATED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NOT COMMUNICATED