BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3171147 · Received June 14, 2013

    Report

    Report Number
    1030489-2013-02310
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S INITIAL DIAGNOSIS WAS DEGENERATIVE DISEASE. IT WAS REPORTED THAT THE SETSCREW COULD NOT BE PLACED AT L5. ¿THE SURGEON THOUGHT THAT L5 EXTENDER WAS ABOUT TO RELEASE THE SCREW HEAD BECAUSE L5 SCREW WAS PLACED MEDIALLY AND S SCREW WAS LATERALLY. WHEN THE SURGEON REMOVED THE EXTENDER TO SEE IF THE SCREW HEAD WAS DAMAGED OR NOT, THE SURGEON FOUND A FRAGMENT OF THE BROKEN SETSCREW. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270521 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1