BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1841906 · Received September 17, 2010

    Report

    Report Number
    1030489-2010-01215
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 20, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    PMA / PMN Number
    K091974
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE THREAD CRESTS AND FLANKS ARE DAMAGED; THIS DAMAGE APPEARS TO HAVE INITIATED AT THE START OF THE THREAD. THIS IS CONSISTENT WITH SET SCREW MISUSE DUE TO CROSS-THREADING. THE EXTENSIVE DAMAGE ON ONE SIDE OF SET SCREWS SUGGEST THREAD JUMPING, IN ADDITION TO CROSS THREADING. 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 DURING A L3-S1 LUMBAR FUSION TO IMPLANT POSTERIOR FIXATION, THE INITIAL SET SCREW WAS CROSS THREADED. AFTER REMOVING THE SET SCREW AND REPLACING A NEW SET SCREW, THE NEW SET SCREW COULD NOT BE TORQUED PROPERLY. THE MULTI AXIAL SCREW THREADS APPEAR TO HAVE BEEN DAMAGED BY THE FIRST CROSS THREADED SCREW. NEW SET SCREWS WERE TRIED BUT NONE COULD BE TORQUED PROPERLY. EVENTUALLY THE MULTI AXIAL SCREW WAS REPLACED WITH A NEW ONE, AND THE NEW SET SCREW WAS TORQUED PROPERLY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SET SCREW KWQ MEDTRONIC SOFAMOR DANEK NA H09M0367

    Patients

    Seq Age Sex Outcome Treatment
    1 PEDICLE SCREW NOT IMPLANTED.