BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 2901015 · Received January 3, 2013

    Report

    Report Number
    3007700286-2012-00085
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 5, 2012
    Report Date
    January 3, 2013
    Manufacturer
    SI-BONE
    Product Code
    OUR
    PMA / PMN Number
    K122074
    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 AND FMEA, THE MOST PROBABLE ROOT CAUSE IS INCORRECT IMPLANT SIZE SELECTION.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A RIGHT SACROILIAC JOINT FUSION ON (B)(6) 2012. THE SURGEON PLACED FOUR IFUSE IMPLANTS. THE IMPLANTS WERE 7X50, 7X45, 7X40 AND 7X40. THERE WERE NO COMPLICATIONS DURING SURGERY. THE PT HAD NO NEW COMPLAINTS OF LEG PAIN AND NO NEW COMPLAINTS OF NUMBNESS OR WEAKNESS IN THE LOWER EXTREMITIES AFTER SURGERY. AS IS HIS HABIT AND CUSTOM, THE SURGEON OBTAINED A CT SCAN THE EVENING OF SURGERY TO CONFIRM THE POSITION OF THE IMPLANTS. ALL OF THE IMPLANTS WERE WELL WITHIN BONE. THERE WAS NO MALPOSITION OF ANY OF THE IMPLANTS. IT WAS THE OPINION OF THE SURGEON THAT THE THIRD FROM THE TOP IMPLANT WAS TOO SHORT. THE SURGEON BROUGHT THE PT BACK TO SURGERY ON (B)(6) 2012 TO REVISE THE THIRD IMPLANT TO A LONGER IMPLANT. AT SURGERY THE SURGEON REMOVED THE 7 X 40 MM IMPLANT AND REPLACED IT WITH A 7 X 45 MM IMPLANT. THE PT HAD NO PAIN COMPLAINTS AND NO NEUROLOGIC COMPLAINTS AFTER THE INDEX SURGERY. THE PT HAD NO NEW PAIN COMPLAINTS AND NO NEUROLOGIC COMPLAINTS AFTER THE REVISION SURGERY. THIS REVISION WAS PERFORMED TO OPTIMIZE THE "LENGTH" OF THE IMPLANTS. THE REVISION WAS PERFORMED ON AN ASYMPTOMATIC PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2715 IFUSE IMPLANT SYSTEM PLATES, SCREWS, RODS OUR SI-BONE

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention