BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORMAGRAFT BONE GRAFT

    MDR report key: 5041747 · Received August 28, 2015

    Report

    Report Number
    MW5055835
    Event Type
    Injury
    Date Received
    August 28, 2015
    Date of Event
    December 17, 2012
    Report Date
    August 28, 2015
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO REPORT ADVERSE REACTION TO FORMAGRAFT IMPLANTS HE RECEIVED ON (B)(6) /2012. PT STATED, THAT EVER SINCE HIS SURGERY, HIS PAIN HAS BECOME WORSE. HE SAID THE PAIN IS ON HIS RIGHT SIDE AND THAT HE CAN FEEL DEEP NERVE PAIN IN HIS TAILBONE. PT SAYS HIS CONDITION AND THE PAIN ONLY CONTINUE TO GET WORSE AND HE DOESN'T KNOW THAT TO DO. HE SAID HE TAKES MORPHINE FOR THE PAIN, BUT IT ONLY HELPS ABOUT 354. HE STATED THAT HE ATTEMPTED TO CONTACT HIS IMPLANTING PHYSICIAN FIVE TIMES AFTER THE SURGERY, BUT WAS NEVER ABLE TO GET IN TOUCH WITH HIM. PT SAID HE IS CURRENTLY ON DISABILITY AND CAN BARELY LEAVE THE HOUSE DUE TO HIS PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570631 FORMAGRAFT BONE GRAFT FORMAGRAFT BONE GRAFT MQV NUVASIVE, INC. 5010125 B120-1201
    570632 FORMAGRAFT BONE GRAFT FORMAGRAFT BONE GRAFT MQV NUVASIVE 5010125 B120-1209

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Disability