BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3963749 · Received July 29, 2014

    Report

    Report Number
    1030489-2014-03328
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    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

    ADDITIONAL INFO: VISUAL AND OPTICAL EXAMINATION OF COMPLAINT RETURN INSTRUMENT DID NOT IDENTIFY MATERIAL ISSUE, WITH RESPECT TO DEFORMATION, CRACK, FRACTURE, OR BREAKAGE. NO MATERIAL WITNESS MARKS NOTED ON ANY OF THE FOUR MAS HEAD ENGAGEMENT TAB AREAS. NO ISSUES WITH OPENING OR CLOSING THE INSTRUMENT WITH A SAMPLE MAS. FUNCTIONAL EVALUATION WITH A SAMPLE MAS AT MAXIMUM ANGULATION AND INSTRUMENT IN MANUAL TENSILE LOAD WAS UNABLE TO MANUALLY INDUCE BINDING OF THE INSTRUMENT. 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. CONCLUSION: THE INSTRUMENT APPEARS TO BE CAPABLE OF PERFORMING ITS INTENDED FUNCTION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION AT T12-L4 TO TREAT A L2 BURST FRACTURE. IT WAS REPORTED THAT THE EXTENDERS WERE NOT ABLE TO BE DISENGAGED FROM THE SCREWS. THE HCP WAS FINALLY ABLE TO REMOVE THE EXTENDERS AFTER USING A ROD HOLDER TO PINCH THE TABS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441413 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK USA, INC NA EM13C012

    Patients

    Seq Age Sex Outcome Treatment
    1 BONE SCREW