BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1649051 · Received March 26, 2010

    Report

    Report Number
    1030489-2010-00414
    Event Type
    Malfunction
    Date Received
    March 26, 2010
    Date of Event
    February 24, 2010
    Report Date
    February 24, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (LOT): THE SET SCREWS WERE USED IN CASE ARE LOT# H09K4758 AND H09J3797. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG# 7540020, 510K# K052187 WAS CLEARED IN THE UNITED STATES. MANUFACTURE DATE FOR LOT H09K4758 IS 11/03/2009; MANUFACTURE DATE FOR LOT H09J3797 IS 10/20/2009. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVAL. 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 PT UNDERWENT A PLF AT L3-L5 USING POSTERIOR FIXATION SYSTEM. THE CROSSLINK WAS IMPLANTED FIRST AND IT BLOCKED THE COUNTER TO BE PLACED ON THE PEDICLE SCREW LEAD. THEREFORE, THE BREAK OFF SET SCREW COULD NOT BE BROKEN OFF AT LEFT SIDE L5. AFTER SEVERAL ATTEMPTS, THE SURGEON OPTED TO CLOSE THE INCISION WITHOUT IMPLANTING THE SET SCREW AT LEFT L5. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SET SCREW KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR PEDICLE SCREWS| IMPLANTED: