BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARAMOUNT (TM) PEDICLE SCREW, 6.5MM X 40MM

    MDR report key: 866572 · Received June 15, 2007

    Report

    Report Number
    3005559743-2007-00001
    Event Type
    Injury
    Date Received
    June 15, 2007
    Date of Event
    May 15, 2007
    Report Date
    May 15, 2007
    Manufacturer
    INNOVATIVE SPINAL TECHNOLOGIES INC (IST)
    Product Code
    MNH
    PMA / PMN Number
    K053276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. AS STATED IN THE INSTRUCTIONS FOR USE THAT ACCOMPANY THIS DEVICE, A CONTRAINDICATION IS ACTIVE INFECTIOUS PROCESS, PARTICULARLY IN OR ADJACENT TO THE SPINE OR SPINAL STRUCTURES.

    Description of Event or Problem · 1

    IN 2007, PATIENT RECEIVED IST VER (L4-L5), IST PEDICLE SCREW SYSTEM (L4-S1 UNILATERAL/IPSILATERAL), AND TRANS1 AXIALIF (L5-S1). THE FOLLOWING MONTH, PATIENT WAS TAKEN TO OR WITH SYMPTOMS OF BACK PAIN. ORIGINAL SURGEON'S PARTNER PRESIDED. PRESENCE OF INFECTION WAS NOTED UPON OPENING ORIGINAL INCISION. CULTURES WERE TAKEN, AREA WAS CLEANED AND IRRIGATED, AND ANTIBIOTIC BEADS PLACED. IMPLANTS WERE NOT CLOSELY EXAMINED AND PATIENT WAS CLOSED. ON FOUR DAYS LATER, ORIGINAL SURGEON REOPENED PATIENT AND EXAMINED IMPLANTS IN SITU. ORIGINAL SURGEON INITIALLY FELT THAT PEDICLE SCREW CONSTRUCT (L4-S1) WAS LOOSE AND DECIDED TO REMOVE IT. DURING REMOVAL ONLY THE L4 SCREW WAS FOUND TO BE LOOSE. ORIGINAL SURGEON DID NOT REPLACE THE CONSTRUCT, PLACED ANTIBIOTIC, AND CLOSED. THE L4 SCREW WAS SENT TO HOSPITAL PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARAMOUNT (TM) PEDICLE SCREW, 6.5MM X 40MM ORTHOSIS, SPINAL PEDICLE FIXATION MNH INNOVATIVE SPINAL TECHNOLOGIES INC (IST)

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R MEDTRONIC SOFAMOR DANEK INFUSE| TRANS1 AXIALIF| IST PARAMOUNT (TM) VBR