BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON

    MDR report key: 3162775 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02158
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 29, 2013
    Report Date
    August 27, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT THE BROKEN TIP WAS NOT RETURNED FOR ANALYSIS BUT WAS REMOVED FROM THE PATIENT. THE T25 TIP IS BROKEN AND TWISTED IN THE SETSCREW TIGHTENING DIRECTION. THE DAMAGES (TWIST AND BREAKAGE) OF THE T25 TIP IS CONSISTENT WITH OVERLOADING IN TORSION APPLIED TO THE DRIVER DURING THE TIGHTENING OF THE SETSCREW. THIS MAY OCCUR WHEN THE SURGEON RETIGHTENED THE SETSCREW AFTER THE INITIAL BREAK-OFF OF THE SETSCREW (THE EVENT DESCRIPTION MENTIONED THAT THE SURGEON USED IT FOR TIGHTENING AN ILIAC MAS SETSCREW).

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE, DURING THE PROCEDURE, IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE AS THE SURGEON WAS ATTEMPTING TO TIGHTEN THE SCREW. THE BROKEN TIP WAS REMOVED AND A NEW DRIVER WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262282 CD HORIZON ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC OT12H013

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR