BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2881254 · Received December 20, 2012

    Report

    Report Number
    1030489-2012-02906
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 26, 2012
    Report Date
    January 11, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    K011508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    MACROSCOPIC AND OPTICAL EXAMINATION DID NOT REVEAL THREAD DAMAGE. FUNCTIONAL EVALUATION WITH A SAMPLE REDUCTION REDUCTION MUTI AXIAL SCREW FOUND THE SET SCREW ABLE TO BE FULLY ENGAGED IN THE MAS HEAD WITHOUT ISSUE. AFTER VISUAL, OPTICAL AND FUNCTIONAL EVALUATION, THE IMPLANT APPEARS TO BE CAPABLE OF PERFORMING ITS INTENDED FUNCTION.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SETSCREWS 'SLID' DURING INSERTION INTO THE BONE SCREW. THE SCREWS WERE REMOVED AND REPLACED. 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 WARSAW ORTHOPEDICS NA 0199727W

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR SCREW