BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITLE2

    MDR report key: 1675865 · Received April 23, 2010

    Report

    Report Number
    2184052-2010-00006
    Event Type
    Malfunction
    Date Received
    April 23, 2010
    Date of Event
    March 17, 2010
    Report Date
    March 25, 2010
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    HXX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEWED DEVICE HISTORY RECORDS. REVIEW OF DHR SHOWS THE DEVICE WAS MANUFACTURED TO ALL SPECS. A REVIEW OF THE INSTRUMENTS RETURNED SHOWED NO MFG DEFECTS, SIGNS OF EXCESSIVE WEAR, OR INCLUSIONS THAT WOULD CAUSE THESE INSTRUMENTS TO NOT PROPERLY FUNCTION. THE REDUCER INSTRUMENT WAS BROKEN WITH A PIN MISSING FROM THE ASSEMBLY WHICH HOLDS TWO OF THE COMPONENTS TOGETHER. THE MISSING PIN IN THE REDUCER INSTRUMENT COULD HAVE CONTRIBUTED TO FAILURE OF THE DEVICE(S) ALTHOUGH IT IS IMPOSSIBLE TO CONCLUDE IF THE REDUCER WAS BROKEN BEFORE, DURING, OR AFTER THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    AFTER IMPLANTING ALL HARDWARE, THE SURGEON NOTICED A PARS DEFECT AT L5 AND WANTED TO REDUCE THE L5 SCREWS. THE SURGEON STRUGGLED TO DISENGAGE THE REDUCER DRIVER FROM THE CAP SCREW. THE SURGEON ATTEMPTED TO REMOVE THE REDUCER DRIVER FROM THE CAP SCREWS BY WIGGLING, ROTATING AND MALLETING IT UP. THE SURGEON WAS ABLE TO DISENGAGE THE REDUCER DRIVER FROM THE CAP SCREW, HOWEVER, THE ENTIRE CONSTRUCT ON THE RIGHT SIDE PULLED OUT OF THE BONE, SEVERLY DAMAGING THE PEDICLES. AS A RESULT, THE SURGEON HAD TO LEAVE THE PT WITH A UNILATERAL FIXATION. THE SURGEON WAS ALSO UNABLE TO CORRECT THE PARS DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITLE2 REDUCER DRIVER HXX ZIMMER SPINE, INC. ET1094-01 L75062

    Patients

    Seq Age Sex Outcome Treatment
    1 Other