BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3070715 · Received April 22, 2013

    Report

    Report Number
    1030489-2013-01175
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 24, 2013
    Report Date
    March 24, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    K954645
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    FILMS WERE SUPPLIED FOR REVIEW WHICH FOUND: LATERAL VIEW OF CONSTRUCT T12-S1 WITH BROKEN ROD ABOVE CROSSLINK. A REVISION WAS NEC ESSARY; PRESUMPTION IS THAT FUSION WAS NOT SOLID.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A L2.3 TUBERCULOSIS CLEANING AND L5 SPONDYLOLISTHESIS REDUCTION SURGERY. APPROXIMATELY 22 MONTHS POST-OP FILMS SHOWED THE ROD BROKEN BETWEEN L2 AND L3. THE PATIENT UNDERWENT A REVISION SURGERY. THE PATIENT UNDERWENT THE T12/L1/L4 SURGERY TO TAKE OUT ALL THE BROKEN RODS AND KEEP THE L5/S1 SPONDYLOLISTHESIS FIXATION. DURING THE SECOND SURGERY THE NEW RODS WERE IMPLANTED. THE SURGERY COMPLETED SMOOTHLY THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171980 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0111439W

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR SCREWS