BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 3192678 · Received June 27, 2013

    Report

    Report Number
    1030489-2013-02570
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    PMA / PMN Number
    K112555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL AND OPTICAL INSPECTION IDENTIFIED DEFORMATION ON THE BONE SCREW HEAD CONSISTENT WITH FULL TIGHTENING OF THE SET SCREW. ADDITIONALLY, WITNESS MARKS ON THE CROWN OF THE SCREW IS ALSO CONSISTENT WITH A FULLY TIGHTENED SET SCREW. AFTER VISUAL, OPTICAL INSPECTION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT OR ASSOCIATED COMPONENTS. THE IMPLANT APPEARS TO BE CAPABLE OF PERFORMING ITS INTENDED FUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SPINAL PROCEDURE. IT WAS REPORTED THAT "THE SCREW HEAD BECAME FIXED ONCE I MPLANTED, WHILE PLACING THE ROD.THE HEAD WAS NO LONGER MULTIAXIAL." NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294672 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS H13A4762

    Patients

    Seq Age Sex Outcome Treatment
    1