BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUOIA SCREWDRIVER, MODULAR

    MDR report key: 1708144 · Received May 27, 2010

    Report

    Report Number
    1649384-2010-00140
    Event Type
    Malfunction
    Date Received
    May 27, 2010
    Date of Event
    April 30, 2010
    Report Date
    May 27, 2010
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    HXX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND NOT IMPLANTABLE. EVALUATION IS PENDING UPON COMPLETED INVESTIGATION OF THE PRODUCT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, DURING A PRIMARY TLIF PROCEDURE FROM T3-S1, THE SURGEON WAS REMOVING A SCREW WHEN THE DISTAL TIP OF THE SEQUOIA MODULAR DRIVER BROKE OFF. THE SURGEON WAS ABLE TO REMOVE THE TIP FROM THE SURGICAL SITE WITHOUT DIFFICULTY AND CONTINUE THE SURGERY AS INDICATED. THERE WAS A MINIMAL SURGICAL DELAY AND NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUOIA SCREWDRIVER, MODULAR SEQUOIA HXX ZIMMER SPINE, INC. NA 61ER

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention