BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 1545674 · Received November 19, 2009

    Report

    Report Number
    MW5013655
    Event Type
    Injury
    Date Received
    November 19, 2009
    Date of Event
    November 16, 2009
    Report Date
    November 19, 2009
    Manufacturer
    SURGICAL INSTRUMENT SERVICE CO
    Product Code
    HTX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MD, WHILE REMOVING THE DISK MATERIAL, THE TIP OF THE INSTRUMENT BROKE OFF IN THE DISC SPACE AND SURGEON UNABLE TO RETRIEVE THE BROKEN TIP DURING SURGERY. PT BROUGHT BACK TO SURGERY THE FOLLOWING DAY FOR INSTRUMENT TIP TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PITUITARY RONGUER HTX SURGICAL INSTRUMENT SERVICE CO * *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| S