BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTYS BCP (510K NUMBER: K073064)

    MDR report key: 3221882 · Received July 11, 2013

    Report

    Report Number
    3006761298-2013-00001
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    July 11, 2013
    Manufacturer
    GRAFTYS
    Product Code
    MQV
    PMA / PMN Number
    K073064
    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 IN (B)(6) RELATED US THE FOLLOWING SITUATION: A SURGEON FROM (B)(6) SAW DELAYED BONE HEALING AFTER "OSTEOMITIES" USING IMPLANT GRAFTYS BCP. HE RECOGNIZED SCLEROTIC BONE AND SEEMED TO BE AROUND IMPLANT. WE DONT' KNOW HOW MANY PTS WERE INVOLVED, NUMBER OF MEDICAL DEVICES USED, LOT NUMBER USED, IF THE ALLEGED INJURY RESULTED IN A IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO THE BODY STRUCTURE OR IF IT NECESSITATED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO THE BODY STRUCTURE. CONSIDERING THE LACK OF INFO IN OUR POSSESSION, WE CAN'T CONCLUDE ON A SERIOUS INJURY, EVEN THOUGH WE DECIDED TO TREAT THAT CASE AS A SERIOUS INJURY. (B)(4) COMPETENT AUTHORITY CONCERNED HAVE BEEN NOTIFIED OF THAT CASE. THE ONLY CONCLUSION WE HAVE IS THAT THIS SITUATION CAN HAPPEN DEPENDING OF THE SURGICAL TECHNIQUE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320007 GRAFTYS BCP (510K NUMBER: K073064) GRAFTYS BCP MQV GRAFTYS NOT COMMUNICATED NOT COMMUNICATED

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT COMMUNICATED.