BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2232530 · Received September 2, 2011

    Report

    Report Number
    1030489-2011-01126
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    PMA / PMN Number
    K102555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LATERAL FUSION AT L3-5. IT WAS REPORTED THAT WHILE PERFORMING FINAL TIGHTENING ON THE RIGHT L3 PEDICLE SCREW THE SET SCREW STRIPPED OUT OF THE SCREW LEAVING A PIGTAIL OF TITANIUM THREAD LOOSE IN THE WOUND. THE SHEARED PIECE WAS REMOVED. THIS OCCURRED WITH A SECOND SETSCREW AS WELL. A THIRD SET SCREW WAS PLACED WITHOUT THE COUNTER TORQUE IN PLACE, TIGHTENED UNDER VISUALIZATION, AND THEN BROKE OFF USING THE COUNTER TORQUE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H11D2782

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR BONE SCREW, DRIVER