BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPINECATH INTRADISCAL CATHETER

    MDR report key: 274802 · Received April 18, 2000

    Report

    Report Number
    2953127-2000-00005
    Event Type
    Other
    Date Received
    April 18, 2000
    Date of Event
    March 13, 2000
    Report Date
    April 17, 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 TIP OF DEVICE BROKE OFF DURING RETRACTION OF DEVICE FROM DISC. DISTAL PORTION OF THE DEVICE REMAINS IN THE INTERVERTEBRAL DISC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINECATH INTRADISCAL CATHETER ELECTROTHERMAL INTRADISCAL CATHETER GEI ORATEC INTERVENTIONS, INC. 902002 122799-04

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other