BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1251934 · Received November 26, 2008

    Report

    Report Number
    1030489-2008-00640
    Event Type
    Injury
    Date Received
    November 26, 2008
    Report Date
    November 3, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPER
    Product Code
    KWP
    PMA / PMN Number
    K042025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: OF THE RECEIVED COMPONENTS INDICATES THAT THE COMPONENTS ARE MEDTRONIC, INC. PRODUCTS. CHEMICAL COMPOSITION ANALYSIS OF A SELECTION OF PARTS WHICH EXHIBIT MATERIAL LOSS AND PARTS WHICH DO NOT EXHIBIT MATERIAL LOSS, STRONGLY SUGGESTS THE MEASURED PARTS WERE FABRICATED WITH MATERIALS THAT MEET THE ASTM SPECIFICATIONS OUTLINED ON THE RESPECTIVE ENGINEERING DRAWINGS. PRECISE MEASUREMENT OF COMPONENT CHEMISTRY CAN ONLY BE PERFORMED WITH A DESTRUCTIVE TECHNIQUE GIVEN THE PRESENCE OF SURFACE CONTAMINANTS. DIMENSIONAL CHARACTERIZATION SHOWED PARTS MEET THE SPECIFICATIONS IN AREAS WHERE CORROSION IS ABSENT. LOCATIONS OF MATERIAL LOSS, TYPICALLY RANGING FROM 0-10%, WERE OBSERVED UNDER MAGNIFICATION USING BOTH OPTICAL AND SCANNING ELECTRON MICROSCOPY. THESE FINDINGS ARE CONSISTENT WITH CREVICE CORROSION WHICH IS A KNOWN RISK FOR ORTHOPAEDIC IMPLANTS. NO COMPONENTS EXHIBITED A STATIC OR FATIGUE FRACTURE, SUGGESTING THE SPINAL CONSTRUCT WAS SUCCESSFUL IN STABILIZING THE SPINE FROM THE TIME OF IMPLANTATION TO THE TIME OF EXPLANTATION. THE RISK OF CREVICE CORROSION WAS EXPLICITLY SET FORTH IN THE PRODUCT LABELING AND PACKAGE INSERT PRIOR TO THE OPERATION. THE RI SK OF CORROSION INCREASES IN AN ACIDIC ENVIRONMENT WHICH IS CREATED BIOLOGICALLY WHEN AN INFECTION OCCURS. THE PATIENT HAD PURULENCE, A SIGN OF INFECTION, AT THE SURGICAL SITE WHEN THE SPINAL SYSTEM WAS EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT SURGERY IN 2007 TO CORRECT SCOLIOSIS IN HER LOWER BACK WHERE RODS SCREWS WITH WIRE WERE IMPLANTED. AT AN UNK TIME AFTER THE PROCEDURE, THE PT DEVELOPED UNEXPLAINED BACK PAIN. EXPLORATORY SURGERY WAS DONE WITH REMOVAL OF HARDWARE. REPORTEDLY THE PT'S WBC COUNT WAS BORDERLINE AT THE TIME, AND SHE DEVELOPED AN UNEXPLAINED PANCREATITIS. REPORTEDLY, THE EXPLANTED SCREWS APPEARED TO BE CORRODED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT T8-PELVIS POSTERIOR FUSION TO TREAT CONGENITAL SCOLIOSIS WITH L5 SPONDYLOLYSIS AND SIGNIFICANT TORSO DECOMPENSATION. AN UNKNOWN TIME POST-OP, THE PATIENT DEVELOPED ONGOING DIFFUSED THORACOLUMBAR BACK PAIN. THE PATIENT HAD AN EXTENSIVE WORKUP INCLUDING A WBC SCAN AND BLOOD WORK ALL WHICH WAS NORMAL. X-RAYS SHOWED A GOOD BALANCED SPINE, NO HARDWARE FAILURE, AND NO LOOSENING OF THE HARDWARE. THE PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE 435 DAYS POST-OP. PER THE OPERATIVE REPORT, THERE APPEARED TO BE SOME BLACK TISSUE DISTALLY AROUND THE DISTAL PEDICLE SCREWS. THERE ALSO APPEARED A POSSIBILITY OF SOME PURULENCE AROUND THE LEFT S1 SCREW. CULTURES WERE TAKEN. AFTER RODS AND SCREWS WERE REMOVED, THE WOUND WAS LIBERALLY IRRIGATED WITH SALINE SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM BONE SCREW KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPER NA H06M5517

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention