BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 496214 · Received November 12, 2003

    Report

    Report Number
    1030489-2003-00126
    Event Type
    Injury
    Date Received
    November 12, 2003
    Report Date
    October 14, 2003
    Manufacturer
    SOFAMORE DANEK - WARSAW
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THERE WAS A REPORT THAT A SURGEON USED CORNERSTONE HSR WITH BMP AND THE PT ALLEGEDLY PRESENTED WITH WEAKNESS OF ALL FOUR LIMBS 48 HOURS POST-OP. A REVISION SURGERY WAS DONE TO ALLEVIATE THE ALLEGED WEAKNESS, BUT THE SYMPTOMS ARE STILL PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT BONE GRAFT SUBSTITUTE NEK SOFAMORE DANEK - WARSAW NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention