BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3123909 · Received May 22, 2013

    Report

    Report Number
    1030489-2013-01821
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE PART # 8690040, LOT #0073518W; PART # 75445545, LOT # H10B4604; PART #75445550, LOT #H09F7512; PART # 7540020, LOT #UNK. THE DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER, 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. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    FILM REVIEW FOUND: MULTIPLE LATERAL VIEWS AND ONE AP X-RAY OF SINGLE LEVEL L2-3 PEDICLE SCREWS WITHOUT INTERBODY DEVICE. L2 HAS HAD ITS UPPER HALF ABSORBED AS WELL AS THE LOWER HALF OF L1. THERE IS DISCONTINUITY OF THE L1-2 SEGMENT WITH RETROLISTHESIS OF L1 ON L2 AND A LARGE ANTERIOR BONY CALCIFICATION SPANNING TO MID T12.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE AT L2-3. APPROXIMATELY 3 YEARS POST-OP THERE WAS CONCERN THAT THE PATIENT HAD AN INFECTION. THE PATIENT UNDERWENT A REVISION SURGERY IN WHICH THE HARDWARE WAS REMOVED AND NEW HARDWARE WAS IMPLANTED FROM T10-L4. THE PATHOLOGY FROM THE INFECTION IS UNKNOWN AT THIS TIME. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226074 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention