BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2181741 · Received July 27, 2011

    Report

    Report Number
    1030489-2011-00950
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 25, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    KWP
    PMA / PMN Number
    K052747
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. MACROSCOPIC AND OPTICAL EXAMINATION OF THE TIP OF THE REDUCTION SLEEVE DID NOT IDENTIFY ANY BREAKAGE OR CRACKING. DIMENSIONAL EXAMINATION OF THE TIP OF THE REDUCTION SLEEVE FOUND THAT THE SLEEVE TIPS ARE BENT OUTWARD OUT OF PRINT SPECIFICATION AT THE MAS HEAD RETENTION FEATURES. VISUAL AND OPTICAL INSPECTION IDENTIFIED MULTIPLE AREAS OF DAMAGE IN THE MAS RETENTION AREA. FUNCTIONAL EVALUATION WAS PERFORMED ON ALL SLEEVES UTILIZING A SAMPLE EXTENDER AND 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. SURGICAL TECHNIQUE FOR THIS PART IS FOR THE SURGEON TO REMOVE THE EXTENDER FROM THE BODY AND SCREW BY ROCKING THE EXTENDER IN A MEDI AL/LATERAL DIRECTION AND PULLING UPWARD. THIS CAN CREATE STRESSES ON THE PART THAT CAN BEND THE TIPS IF PERFORMED AGGRESSIVELY. WITNESS MARKS ON THE UPPER WALLS, THE BENT TIP CONDITION OF THE INNER SLEEVE, AND THE RECENT LOT DATE CODE OF THE EVALUATED PRODUCT SUGGEST THAT AGGRESSIVE RELEASE TECHNIQUES MAY HAVE BEEN UTILIZED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INNER SLEEVE OF THE ROD INSERTER WOULD NOT HOLD THE SCREW IN A MINI-INVASIVE SPINAL PROCEDURE. ALTHOUGH THE INSTRUMENT WAS USED INTRAOPERATIVELY, NO PATIENT INJURY WAS 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 FA08K014

    Patients

    Seq Age Sex Outcome Treatment
    1