BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2132876 · Received June 17, 2011

    Report

    Report Number
    1030489-2011-00763
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Report Date
    June 20, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    NKB
    PMA / PMN Number
    K063417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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; THE TIP-TO-TIP DIMENSION; ALL MEASUREMENTS WERE FOUND TO BE OUT OF PRINT SPECIFICATION. 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. A COMMON SURGICAL TECHNIQUE FOR INSTRUMENT REMOVAL IS FOR THE SURGEON TO REMOVE THE EXTENDER FROM THE BODY AND SCREW BY ROCKING THE EXTENDER IN A MEDIAL/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 SLEEVES, 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). 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. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    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 MINIMAL ACCESS SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE INNER SLEEVE EXTENDER DISLODGED FROM THE PEDICLE SCREW. THIS OCCURRED SEVERAL MORE TIMES. AFTER SEVERAL HOURS INTO THE SURGERY, IT WAS DECIDED TO ABORT THE CASE DUE TO THE EXTENDERS NOT WORKING PROPERLY. ANOTHER SYSTEM WAS USED TO FINISH THE CASE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA RS10C041

    Patients

    Seq Age Sex Outcome Treatment
    1 Other