BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1992019 · Received February 15, 2011

    Report

    Report Number
    1030489-2011-00130
    Event Type
    Injury
    Date Received
    February 15, 2011
    Report Date
    February 17, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    K091974
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NON-UNION. THE DEVICES WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. FILMS WERE SUPPLIED FOR MEDICAL ADVISOR REVIEW. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NONCONFORMANCE TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. VISUALLY CONFIRMED RODS ARE BROKEN. WITNESS MARK BELOW FRACTURE INITIATION SITES SUGGEST FAILURE DUE TO BEND STRESS OVERLOAD; FRACTURE SURFACE MORPHOLOGY (FAIRLY FLAT FRACTURE WITH VISIBLE RIVER LINES AND SHEAR LIP), ALSO SUGGESTS BENDING MOMENT. FRACTURE SURFACE IS MODERATELY TO SEVERELY DAMAGED (~25-75%). X-RAY REVIEW SHOWS SCOLIOSIS CONSTRUCT T10-SACRUM WITH PELVIC SCREW AND BROKEN RODS AT L5. REVISION FILMS SHOW EXTENSION TO T3 IN AP AND LATERAL WITH LATERAL CONNECTORS AT T10 ON THE LEFT SIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LATERAL FUSION AT T10-PELVIS. APPROXIMATELY 1 YEAR POST-OP DURING A ROUTINE VISIT, IT WAS FOUND THAT BOTH RODS HAD BROKEN AT L5-S1 AND THERE WAS A NON-UNION AT THAT LEVEL. THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION REVISION PROCEDURE. THE RODS WERE REPLACED AND THE CONSTRUCT WAS EXTENDED UP TO T9 DUE TO THE PATIENT EXPERIENCING RADICULOPATHY STEMMING FROM T9-10 NERVE ROOT IMPINGEMENT. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE CONSTRUCT WAS EXTENDED UP TO T3 DUE TO THE PATIENT EXPERIENCING RADICULAPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA 0058897W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS