BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE

    MDR report key: 2213279 · Received August 4, 2011

    Report

    Report Number
    MW5021729
    Event Type
    Injury
    Date Received
    August 4, 2011
    Report Date
    August 2, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AN ONLINE ARTICLE WAS IDENTIFIED: BACK SURGERY PT SUES STRYKER AND MEDTRONIC FOR INJURIES AND OFF LABEL PROMOTION OF CALSTRUX / OP-1 PUTTY AND INFUSE - (B)(4). THE ARTICLE DESCRIBES A FEMALE PT WHO SUFFERED A HERNIATED DISC DURING A CAR ACCIDENT. THE PT REPORTEDLY EXPERIENCED WORSENING OF HER BACK PAIN AFTER RECEIVING MEDTRONIC INFUSE BONE GRAFT AS PART OF A REVISION SURGERY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE INFUSE BONE GRAFT NEK MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S