BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 3173722 · Received June 17, 2013

    Report

    Report Number
    1030489-2013-02340
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NKB
    PMA / PMN Number
    K122862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICES HAVE BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: VISUAL AND OPTICAL EXAMINATION OF COMPLAINT RETURN INSTRUMENT DID NOT IDENTIFY MATERIAL ISSUE, WITH RESPECT TO DEFORMATION, CRACK, OR FRACTURE. NO ISSUES WITH OPENING OR CLOSING THE INSTRUMENT MULTIPLE TIMES WITH AND WITHOUT SAMPLE MAS, AND THE MAS HEAD WAS REMOVED WITHOUT DIFFICULTY. UNABLE TO REPLICATE CUSTOMER CONCERN; AFTER VISUAL, OPTICAL AND FUNCTIONAL EVALUATION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT OR ASSOCIATED COMPONENTS. THE INSTRUMENT APPEARS TO BE CAPABLE OF PERFORMING ITS INTENDED FUNCTION.

    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 UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE AT L1-3 ALONG WITH A VERTEBROPLASTY AT L2 (USING COMPETITOR PRODUCT) TO TREAT A TRAUMATIC INJURY. IT WAS REPORTED THAT THE EXTENDERS WOULD NOT DISENGAGE FROM THE BONE SCREW ON INITIAL TRY. EVENTUALLY THE EXTENDERS RELEASED FROM THE BONE SCREW. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274046 CD HORIZON® SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK USA, INC NA EM12J035

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR