BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1744176 · Received June 28, 2010

    Report

    Report Number
    1030489-2010-00865
    Event Type
    Malfunction
    Date Received
    June 28, 2010
    Date of Event
    May 31, 2010
    Report Date
    May 31, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED; THEREFORE, THE MFR CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE LOT # H09E6552, H09L6927, AND W08E2912. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 75445545, 510K # K042025 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT H09E6552 IS (B)(4) 2009; THE MANUFACTURE DATE FOR LOT H09L6927 IS (B)(4) 2009; THE MANUFACTURE DATE FOR LOT AND W08E2912 IS (B)(4) 2008. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECS.

    Description of Event or Problem · 1

    DURING THE REVISION SURGERY TO IMPACT THE INTERBODY DEVICE TO REPLACE THE OLD ONE AT L4-L5, THE RIGHT L5 SCREW (THE SCREW WAS IMPLANTED AT PREVIOUS SURGERY) LOOSENING WAS SUSPECTED, SO THE SCREW WAS REPLACED TO A LARGER SIZE TOO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM BONE SCREW KWQ MEDTRONIC SOFAMOR DANEK MSD316 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR SET SCREWS| CAGES| IMPLANT:| ROD| IMPLANT:| IMPLANT:| EXPLANT: