BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPINECATH INTRADISCAL CATHETER

    MDR report key: 283861 · Received June 22, 2000

    Report

    Report Number
    2953127-2000-00008
    Event Type
    Other
    Date Received
    June 22, 2000
    Date of Event
    April 14, 2000
    Report Date
    June 22, 2000
    Manufacturer
    ORATEC INTERVENTIONS, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DISTAL PORTION OF DEVICE BROKE OFF IN PT'S DISC. IT WAS SURGICALLY REMOVED WITH NO ADVERSE SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINECATH INTRADISCAL CATHETER ELECTROTHERMAL INTRADISCAL CATHETER GEI ORATEC INTERVENTIONS, INC. 902002 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other