BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTERGRAFT PUTTY

    MDR report key: 2192786 · Received August 5, 2011

    Report

    Report Number
    1030489-2011-01009
    Event Type
    Injury
    Date Received
    August 5, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MQV
    PMA / PMN Number
    K051386
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A DENTAL PROCEDURE USING PUTTY IMPLANTED IN AN EXTRACTION SOCKET. PRIMARY CLOSURE WAS DONE. TWO DAYS POST-OP, THE PATIENT RETURNED TO HAVE THE SUTURES REMOVED. A WEEK AND A HALF POST-OP, THE TISSUE ON TOP OF THE SOCKET HAD NECROSED. THE GRAFT WAS EXPOSED WITH DENUDATION OF SOCKET WALLS FROM THE INSIDE-INSIDE THE SOCKET WAS VERY DRY. IT TOOK THREE WEEKS TO GET IT COVERED. THE SURGEON FEELS THAT "THE GRAFT MATERIAL IS DRYING OR ABSORBING THE BLOOD CLOT A LOT DEPRIVING THE WALLS FROM THE NECESSARY ELEMENT TO HEAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASTERGRAFT PUTTY FILLER, BONE VOID, CALCIUM COMPOUND MQV MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention