BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2024154 · Received March 18, 2011

    Report

    Report Number
    1030489-2011-00304
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 15, 2011
    Report Date
    April 5, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    KWP
    PMA / PMN Number
    K063417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS 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

    VISUAL EXAMINATION OF THE TIP OF THE REDUCTION SLEEVE FOUND THAT THE SLEEVE TIPS ARE WITHIN PRINT SPECIFICATION AT THE MAS HEAD RETENTION FEATURES. VISUAL AND OPTICAL INSPECTION DID NOT IDENTIFY ANY MATERIAL DAMAGE RELATIVE TO THE INNER SLEEVE TIP THAT WOULD INDICATE MISUSE. A FUNCTIONAL WAS PERFORMED; THE SUBJECT INSTRUMENT PROPERLY RETAINED BOTH LMC AND MMC MATING PART SIMULATIONS. ADDITIONALLY, A FUNCTIONAL EVALUATION WAS PERFORMED ON ALL SLEEVES AND EXTENDERS UTILIZING A SAMPLE MULTI-AXIAL SCREW (MAS); THE MAS HEAD WAS UNABLE TO BE MANUALLY PULLED OUT OF THE INNER SLEEVES WITH THE BONE SCREW AT MAXIMUM ANGULATION. DIMENSIONALLY EVALUATED M12 THREAD UTILIZING GAGES, THE M12 THREADS PASSED BOTH GAGE EVALUATIONS, AS WELL AS 3MM FLAT DIMENSION. THE 3MM FLAT WAS EVALUATED WITH A PIN GAGE, AND FOUND TO BE WITHIN PRINT SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A MINIMAL ACCESS SURGICAL PROCEDURE. IT WAS REPORTED THAT THE EXTENDER WOULD POP OFF OF THE SCREW. THE SURGERY TECHNIQUE WAS CONVERTED TO A MINI OPEN PROCEDURE. NO ADDITIONAL 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 INSTRUMENT MANUFACTURING NA SA09E219Z

    Patients

    Seq Age Sex Outcome Treatment
    1