BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3820442 · Received May 15, 2014

    Report

    Report Number
    MW5036143
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    December 15, 2005
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012 PT UNDERWENT L4-5, L5-S1 LUMBAR LAMINECTOMY AND FUSION UTILIZING MEDTRONIC INFUSE BONE GRAFT WITHOUT LT-CAGE IN MANNER CONTRAINDICATED TO PMA00058. INFUSE WAS USED IN COMBINATION WITH SYNTHES CLICK-X PEDICLE SCREWS (B)(4). MEDICAL RECORDS INDICATE MEDTRONIC SALES REP WAS CONTACTED PRE-OPERATIVELY ON USE OF INFUSE BONE GRAFT WITHOUT REQUIRED LT-CAGE CONTRARY TO STATUTES ON "OFF-LABEL" PROMOTION. PT DEVELOPED POST-OPERATIVE COMPLICATIONS INCLUDING BUT NOT LIMITED TO, BLADDER CANCER, ECTOPIC BONE GROWTH AT IMPLANT DEVICE SITE AND PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292557 INFUSE BONE GRAFT NONE MQV MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| O| R| S SYNTHES CLICK -X PEDICLE SCREWS (B)(4)