BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1122832 · Received August 14, 2008

    Report

    Report Number
    1030489-2008-00440
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 21, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    NQP
    PMA / PMN Number
    K061915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED; THEREFORE PRODUCT EVALUATION IS NOT POSSIBLE AT THIS TIME. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR L5-S1 TLIF WITH PEEK INTERBODY DEVICE AND POSTERIOR FIXATION AT L4-S1 WITH SEMI RIGID RODS AND PEDICLE SCREWS. FIVE AND A HALF MONTHS POST-OP, IT WAS NOTICED THAT A SETSCREW IN ONE OF THE L4 SCREWS HAD BACKED OUT. NO REVISION SURGERY IS PLANNED. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT AND MOVEMENT OF THE SETSCREW. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SETSCREW NQP WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR