BEUDAMED
    FDA Adverse Event Other Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 3210829 · Received July 2, 2013

    Report

    Report Number
    3007700286-2013-00044
    Event Type
    Other
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    July 2, 2013
    Manufacturer
    SI-BONE
    Product Code
    OUR
    PMA / PMN Number
    K123850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE COMPLAINT INFORMATION AND INVESTIGATION, AS WELL AS REVIEW OF THE SURGEON TRAINING MANUAL, IFU AND FMEA, THE MOST PROBABLE ROOT CAUSE IS A MALPOSITIONED IMPLANT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE SURGEON PERFORMED A LEFT SIDE JOINT ARTHRODESIS ON THE PATIENT USING THE IFUSE IMPLANT SYSTEM. THE PATIENT RETURNED TO THE SURGEON APPROXIMATELY THREE WEEKS AFTER THE INITIAL IFUSE SURGERY COMPLAINING OF SCIATIC TYPE PAIN. THE SURGEON PERFORMED A CT SCAN AND NOTED THAT THE THIRD IMPLANT WAS NOT FAR ENOUGH INTO THE SACRUM AND WAS ALSO A BIT INFERIOR. ON (B)(6) 2013, THE SURGEON PERFORMED A REVISION SURGERY. HE FIRST REMOVED THE THIRD (CAUDAL) IMPLANT. THE HOLE FROM THE REMOVAL WAS LEFT EMPTY. THE SURGEON NEXT ADDED ONE ADDITIONAL 4X45MM IFUSE IMPLANT BETWEEN THE INITIAL FIRST AND SECOND IMPLANTS AND POSITIONED MORE ANTERIORLY. PER SI-BONE (B)(4), "MEDICAL REVIEW OF THIS CASE SHOWS THAT THIS IS AN EARLY REVISION FOR TREATMENT OF A SYMPTOMATIC MALPOSITIONED IMPLANT. THE IMPLANT WAS THE THIRD (CAUDAL) IMPLANT AND WAS MALPOSITIONED INFERIORLY. THE PATIENT HAD RADICULAR TYPE SYMPTOMS WITHOUT NEUROLOGIC DEFICIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300850 IFUSE IMPLANT SYSTEM PLATES, SCREWS, RODS OUR SI-BONE

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention