BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTYS HBS (510K NUMBER: K082498)

    MDR report key: 3221883 · Received July 11, 2013

    Report

    Report Number
    3006761298-2013-00003
    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 MFG SITE IN (B)(4) 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 YR 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 (B)(6) RELATED TO US THE FOLLOWING SITUATION: PT HAD PRIOR SURGERY A MANDIBLE FRACTURE WITH A SMALL LOOSE OF BONE IN CONSEQUENCE OF AN INFECTION. WHEN INFECTION WAS TREATED, PT UNDERWENT SURGERY FOR A REDUCTION OF THE FRACTURE. HE HAD HBS FILLING WITH 2 LOCKING PLATES. WE DON'T KNOW HOW MANY DEVICES HAVE BEEN USED. RESULTS: AFTER 6 WEEKS PT HAD AN EDEMA LOOSING THE GRAFT, AND NEEDED TO BE REOPERATED. THE EVENT OCCURRED IN (B)(6). (B)(4) COMPETENT AUTHORITY CONCERNED, 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 RESULTS. IN ADDITION TO THAT, BODY SITE WITH PRIOR INFECTION SHOULDN'T BE TREATED WITH GRAFTYS HBS AS IT IS SPECIFIED IN THE INSTRUCTION FOR USE. AND PHENOMENA OF NON FUSION CAN OCCUR SOMETIMES AS BEING PT DEPENDENT (THIS IS AN ADVERSE EXPECTED EVENT). 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
    319920 GRAFTYS HBS (510K NUMBER: K082498) GRAFTYS HBS MQV GRAFTYS NOT COMMUNICATED NOT COMMUNICATED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NOT COMMUNICATED