BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3114386 · Received May 15, 2013

    Report

    Report Number
    1030489-2013-01708
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FILM REVIEW FOUND: TWO AP VIEWS OF SCOLIOSIS CONSTRUCT T1-T12. ROD EXTENSION FOR JUVENILE PATIENT SET UP WITH 2 LATERAL CONNECTORS AND ROD OVERLAP ON EITHER SIDE. NO EVIDENCE OF THE SET SCREW STRIPPING IS NOTED ON THE X-RAY.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 8549305, 510K # K020709 WAS CLEARED IN THE UNITED STATES. THE DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER, FILMS WERE SUPPLIED FOR REVIEW. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MULTIPLE SURGERIES DUE TO GROWTH TO TREAT SCOLIOSIS. NO SETSCREWS WERE REPLACED IN THE 4TH SURGERY. IT WAS REPORTED THAT DURING 5TH GROWING-ROD PROCEDURE, THE DOMINO SETSCREW'S SCREW HOLE STRIPPED DURING THE FINAL TIGHTENING. THE SURGEON TRIED TO UNSCREW THE SETSCREW IN MANY WAYS, BUT HE COULD NOT REMOVE THE SETSCREW. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DAMAGED SETSCREW BECAUSE THE DOMINO WAS LOCATED IN AN AREA WHICH DID NOT FURTHER AFFECT GROWING-ROD PROCEDURES. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214372 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00010 YR