BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC - SOFAMER DANEK

    MDR report key: 701507 · Received April 5, 2006

    Report

    Report Number
    701507
    Event Type
    Other
    Date Received
    April 5, 2006
    Date of Event
    March 9, 2006
    Report Date
    March 23, 2006
    Manufacturer
    MEDTRONIC
    Product Code
    HTW
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT POSTERIOR CERVICAL LAMINECTOMY AND WIDE FORAMENECTOMY BILATERALLY AT C5-6 AND C6-7 FOR DECOMPRESSION STENOSIS, POSTERIOR CERVICAL FUSION FROM C4-C7 WITH INFUSE BONE MORPHOGENETIC PROTEIN. LOCAL BONE FROM DECOMPPRESSION AND ICN DEMINERALIZED BONE MATRIX STRIPS WITH CORTICAL CANCELLOUS ALLOGRAFT CHIPS, C4-C7 BILATERAL SEGMENTAL FIXATION WITH MEDTRONIC TITANIUM VERTEX MORX LATERAL MASS SCREWS AND PEDICLE SCREWS, AND INTRAOPERATIVE FLUOROSCOPY FOR PLACEMENT OF POSTERIOR CERVICAL FIXATION. THE DRILL BIT BENT AS IT WAS BEING USED ON THE POSTERIOR CERVICAL AREA. PT COMPLICATIONS ARE UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC - SOFAMER DANEK 2.4MM DRILL BIT HTW MEDTRONIC * UQ05M002

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other