BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGENIX DBM PUTTY

    MDR report key: 2810274 · Received October 31, 2012

    Report

    Report Number
    1030489-2012-01996
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    October 1, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NUN
    PMA / PMN Number
    K080462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WITH THE AVAILABLE INFORMATION A CAUSE OR CONTRIBUTING FACTOR CANNOT BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SOCKET GRAFT BONE PROCEDURE WAS PERFORMED USING "STANDARD PROTOCOL PROCEDURE". THE PROCEDURE WAS REPORTED TO BE A FAILURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTCOME OF THE BONEGRAFT PRODUCT WAS A FAILURE AND THAT THE SURGICAL GRAFT PROCEDURE HAD TO BE REDONE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGENIX DBM PUTTY BONE GRAFTING MATERIAL, HUMAN SOURCE NUN MEDTRONIC SOFAMOR DANEK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R