BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3163035 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02164
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 29, 2013
    Manufacturer
    WARSAW ORTHOPEDICS, INC.
    Product Code
    KWP
    PMA / PMN Number
    K050809
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT NO PRE-EXISTING DEFECT WAS FOUND AT THE LEVEL OF THE BREAKAGE. THE BREAKAGE IS CONSISTENT WITH A FATIGUE DAMAGING OF THE METAL DUE TO REPEATED FLEXURAL LOADING OF THE BONE SCREW. NO DEVIATION OR NO NON-CONFORMANCE TO SPECIFICATIONS HAS BEEN RECORDED FOR THIS LOT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF RADIOGRAPHIC IMAGES SHOWS MULTIPLE FILMS ARE RECEIVED INCLUDING AP/LATERAL X-RAYS AND MRI DONE PRIOR TO AND AFTER REVISION. RIGHT L3 SCREW APPEARS TO HAVE BROKEN AND WAS REVISED (SCREW FRAGMENTS PHOTO IN BAG). REVISION EXTENDED L3-L4-L5-S1 CONSTRUCT TO L2-L3-L4-L5-S1 WITH PEDICLE SCREWS AND PEEK RODS. RESULTS ARE INCONCLUSIVE.

    Additional Manufacturer Narrative · 1

    (B)(6). (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

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. AT AN UNKNOWN TIME POST-OP, IT WAS REPORTED THAT A SCREW WAS BROKEN. THE PATIENT CLAIMS BACK PAIN. A REVISION WAS DONE TO REMOVE THE BROKEN SCREW. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262082 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS, INC. 0191480W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R