BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1915382 · Received November 3, 2010

    Report

    Report Number
    1030489-2010-01424
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 24, 2008
    Report Date
    October 2, 2024
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    NQP
    PMA / PMN Number
    K060615
    Removal / Correction Number
    1030489-122107-009R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS CANNOT BE PERFORMED WITHOUT ADDITIONAL DEVICE INFO. WITHOUT RETURN OF THE DEVICE OR ASSOCIATED RECORDS IT IS NOT POSSIBLE TO ASCERTAIN A CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    REVIEW OF ADDITIONAL MEDICAL RECORDS FINDS NO INDICATION THAT THE HARDWARE HAS BEEN REMOVED, AND NO INFORMATION THAT SUGGESTS IMMINENT REVISION.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES A BROKEN ROD. REVIEW OF INITIAL OPERATIVE REPORT FOUND THAT THE PT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) L5-S1, WITH POSTERIOR STABILIZATION OF L4-L5 WITH THE USER OF ROD, SCREWS, INTERBODY SPACER, AND ALLOGRAFT, AUTOGRAFT/HIP ASPIRATION. APPROXIMATELY 6 MONTHS POST IMPLANT RADIOGRAPHS SHOW NO EVIDENCE OF HARDWARE FAILURE. APPROXIMATELY 12 AND 24 MONTHS POST IMPLANT RADIOGRAPHS SUGGESTED A BROKEN ROD CABLE. NO OTHER COMPLICATIONS ARE NOTED. NO RECORD OF REVISION SURGERY HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION NQP WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female UNK.