BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2120598 · Received June 10, 2011

    Report

    Report Number
    1030489-2011-00720
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    PMA / PMN Number
    K102555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SCREW WAS RETURNED FOR EVALUATION. MACROSCOPIC AND OPTICAL EXAMINATION OF THE SET SCREW THREADS IDENTIFIED THREAD CREST AND FLANK DAMAGE. THE DAMAGE APPEARS TO HAVE INITIATED AT THE START OF THE THREAD, AND IS CONSISTENT AROUND THE THREAD; THE TYPE, LOCATION AND NATURE OF DAMAGE IS CONSISTENT WITH SET SCREW MISUSE DUE TO MISALIGNMENT OF THE MAS HEAD AND SET SCREW THREADS. 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 SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SET SCREW CROSS THREADED DURING INSERTION AND METAL SHAVINGS CAME OFF OF THE SCREW. THE SCREW WAS REMOVED AND A NEW SCREW WAS IMPLANTED. NO PATIENT 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 H10M3272

    Patients

    Seq Age Sex Outcome Treatment
    1 BONE SCREW