BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1903869 · Received November 20, 2010

    Report

    Report Number
    1030489-2010-01482
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    PMA / PMN Number
    K091974
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BONE SCREW NOT IMPLANTED; SET SCREWS NOT IMPLANTED. (B)(4). THE DEVICES WERE RETURNED FOR EVALUATION. MACROSCOPIC AND OPTICAL EXAMINATION OF THE SET SCREWS REVEALED THE THREAD CRESTS AND FLANKS ARE DAMAGED; THIS DAMAGE APPEARS TO HAVE INITIATED AT THE START OF THE THREAD, CONSISTENT WITH SET SCREW MISUSE DUE TO MISALIGNMENT OF THE MAS HEAD AND SET SCREW THREADS. ADDITIONALLY, SEVERE DAMAGE ON ONE SIDE SUGGEST THREAD JUMPING. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A 360 ANTERIOR LUMBAR INTERBODY FUSION AT L4-S1. AFTER SUCCESSFULLY BREAKING OFF THE SET SCREWS AT L4 AND S1, SHAVINGS FROM THE SET SCREW AT L5 WERE COMING OFF WHILE TRYING TO INSERT THE BONE SCREW. THREE MORE SET SCREWS WERE TRIED BEFORE IT WAS DECIDED TO REMOVE THE BONE SCREW. THE SET SCREWS AT L4 AND S1 WERE REMOVED SO THE ROD COULD BE REMOVED. THE BONE SCREW AT L4 WAS REMOVED AND REPLACED AND THE ROD WAS RETURNED TO ITS POSITION. THE SET SCREWS WERE BROKEN OFF WITH NO PROBLEMS AT S1 AND L5, BUT METAL SHAVINGS WERE COMING OFF OF THE SET SCREW AT L4. AFTER ANOTHER SETSCREW WAS ATTEMPTED WITH THE SAME FAILURE, IT WAS DECIDED TO REMOVE THE BONE SCREW AT L4. THE SET SCREWS AT L5 AND S1 WERE REMOVED ALONG WITH THE ROD. THE BONE SCREW AT L4 WAS REMOVED AND REPLACED AND THE ROD WAS PLACED BACK IN POSITION. THE SET SCREWS WERE BROKEN OFF WITH SUCCESS AT ALL THREE LEVELS. NO OTHER COMPLICATIONS WERE 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 PUERTO RICO OPERATIONS NA H09L7824

    Patients

    Seq Age Sex Outcome Treatment
    1