BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 2831619 · Received November 7, 2012

    Report

    Report Number
    3007700286-2012-00063
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 17, 2012
    Report Date
    November 7, 2012
    Manufacturer
    SI-BONE
    Product Code
    OUR
    PMA / PMN Number
    K080398
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE COMPLAINT INFO AND INVESTIGATION, AS WELL AS REVIEW OF THE SURGEON TRAINING MANUAL AND FMEA, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE ROOT CAUSE IS MALPOSITION OF THE IFUSE IMPLANT.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A BILATERAL IFUSE PROCEDURE ON (B)(6) 2012. THE PT BEGAN COMPLAINING OF LEFT SIDED LEG PAIN IMMEDIATELY AFTER SURGERY. THE PT HAD NO OBVIOUS MOTOR WEAKNESS OR SENSORY DEFICIT EXAMINATION. THE LEFT LEG PAIN WORSENED OVER THE NEXT FEW DAYS. A CT SCAN SHOWED THAT THE PROXIMAL IMPLANT ON THE LEFT SIDE WAS ANGLED SOMEWHAT CEPHALAD AND BROACHED THE CORTEX OF THE SACRAL ALA. ON (B)(6) 2012, THE SURGEON PERFORMED A REVISION SURGERY TO REMOVE THE PROXIMAL IMPLANT ON THE LEFT SIDE. IMPLANT WAS NOT REPLACED, NO NEW IMPLANTS WERE PLACED, AND NO BONE GRAFT WAS PLACED IN THE HOLE LEFT BY THE REMOVED IMPLANT. THE PT'S LEG PAIN HAD RESOLVED COMPLETELY BY (B)(6) 2012. THE PT HAS NO RESIDUAL LEG PAIN COMPLAINTS. THE PT HAS NO RESIDUAL NUMBNESS OR WEAKNESS OF THE LOWER EXTREMITIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention