BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERPOS FUSION FACET PREP KIT

    MDR report key: 2151113 · Received June 20, 2011

    Report

    Report Number
    2032499-2011-00093
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 15, 2011
    Manufacturer
    INTERVENTIONAL SPINE, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON PLACED RASP INTO FACET JOINT TO BEGIN DECORTICATING THE FACET JOINT. AFTER A COUPLE OF MOTIONS ANTERIOR/POSTERIOR, HE STOPPED TO TAKE FLUOROSCOPY IMAGE. WHEN HE BEGAN TO RESTART HIS ANTERIOR/POSTERIOR MOTION, HE APPLIED VERY LITTLE DOWNWARD PRESSURE AND THE DISTAL TIP OF THE RASP FRACTURED OFF IN THE FACET JOINT. IT WAS FAIRLY DEEP IN THE JOINT, HOWEVER, THE MORE HE ATTEMPTED TO RETRIEVE THE BROKEN PIECE, THE MORE ANTERIOR THE PIECE WENT. AT THE POINT, HE DECIDED TO CHANGE HIS PLAN IN ORDER TO SAFELY REMOVE THE BROKEN PIECE OF RASP. HE DECIDED THAT IT WOULD BE NECESSARY TO DO A COMPLETE FACETECTOMY WITH A CONTRALATERAL DECOMPRESSION AND USE A PEDICLE SCREW CONSTRUCT INSTEAD OF FACET SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERPOS FUSION FACET PREP KIT HTW INTERVENTIONAL SPINE, INC. 9066-00 011910-C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention