BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3033549 · Received April 3, 2013

    Report

    Report Number
    1030489-2013-00930
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOCATION : HOSPITAL. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    INTERNAL HEX OF IMPLANT PLASTICALLY DEFORMED. THE ORIENTATION OF A PORTION OF THE DEFORMATION OF THE HEX FEATURES PROVIDE SOME EVIDENCE OF AN OFF-AXIS ORIENTATION OF THE HEX DRIVER TO THE SET SCREW DURING ATTEMPTED TIGHTENING. THE ABOVE FINDINGS ARE CONSISTENT WITH MISALIGNMENT OF THE DRIVER TIP TO THE SET SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO ALLOW THE GROWTH RODS TO EXPAND. IT WAS REPORTED THAT DURING THE TIGHTENING OF THE DOMINO SETSCREW, THE SETSCREW STRIPPED AND WAS UNABLE TO BE UNSCREWED. AN ADDITIONAL INCISION WAS MADE TO REMOVE THE ROD WITH THE DOMINO. A NEW ROD WAS PLACED TO REBUILD THE CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135933 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0170969W

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR Required Intervention