BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3051254 · Received April 10, 2013

    Report

    Report Number
    1030489-2013-00982
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #A REVIEW OF THE DEVICE MANUFACTURING RECORDS FOR THE INFUSE BONE GRAFT IS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SURGERY USING RHBMP-2/ACS. POST-OP, THE PATIENT DEVELOPED "SIGNIFICANT PAIN, REQUIRED ME TO UNDERGO A REVISION SURGERY, AS WELL AS CAUSED PHYSICAL LIMITATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152111 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention