BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TETHER ANTERIOR CERVICAL FIXATION SYSTEM

    MDR report key: 1628938 · Received March 9, 2010

    Report

    Report Number
    1530901-2010-00002
    Event Type
    Malfunction
    Date Received
    March 9, 2010
    Report Date
    March 9, 2010
    Manufacturer
    THEKEN SPINE LLC
    Product Code
    KWQ
    PMA / PMN Number
    K010466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INITIAL REPORTER; THIS WAS THE SURGEON'S FIRST SURGERY WITH THE TETHER SYSTEM. THE SURGEON WAS DRIVING THE 2ND TO LAST SCREW INTO THE PLATE WHEN THE TIP OF THE INSERTER BROKEN OFF IN THE SCREW HEAD. THE SURGEON WAS NOT ABLE TO REMOVE THE TIP FROM THE SCREW. (B)(6) WAS NOT SURE IF THE LOCKING MECHANISM WAS ENGAGED AS THE SURGERY WAS BEING CONDUCTED UNDER A MICROSCOPE AND THERE WAS NO DISPLAY MONITOR FOR VIEWING. THE LAST SCREW WAS PUT IN PLACE USING ONE OF THE SPARE DRIVERS IN THE SET. THE FOUR-WEEK X-RAY DID NOT SHOW ANY PROBLEMS. THERE WAS NO SCREW BACKOUT OR MOVEMENT VISIBLE ON THE X-RAY, & THE DRIVER TIP HAD NOT DISLODGED FROM THE SCREW HEAD.

    Description of Event or Problem · 1

    THE TIP OF A SCREW DRIVER BROKE OFF IN THE HEAD OF THE SCREW AND COULD NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TETHER ANTERIOR CERVICAL FIXATION SYSTEM SPINAL INTERVERTEBRAL FIXATION ORTHOSIS KWQ THEKEN SPINE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1