BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SOFAMOR DANEK

    MDR report key: 546785 · Received September 23, 2004

    Report

    Report Number
    546785
    Event Type
    Injury
    Date Received
    September 23, 2004
    Date of Event
    September 20, 2004
    Report Date
    September 21, 2004
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    GZX
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE REMOVING DISC (L 4-5) FROM DISC SPACE PITUITARY BITER TIP BROKE OFF IN DISC SPACE, SEVERAL ATTEMPTS, TO RETRIEVE THE TIP, BY SURGEON UTILIZING X-RAY AND SEVERAL INSTRUMENTS WERE UNSUCCESSFUL. SURGEON STATES MORE OF A RISK TO CONTINUE ATTEMPT OR REMOVAL THAN TO LEAVE IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SOFAMOR DANEK SPINAL PITUITARY (1 MM) BITER GZX MEDTRONIC SOFAMOR DANEK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention