BEUDAMED
    FDA Adverse Event Other Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 2933175 · Received January 24, 2013

    Report

    Report Number
    3007700286-2013-00003
    Event Type
    Other
    Date Received
    January 24, 2013
    Date of Event
    December 25, 2012
    Report Date
    January 24, 2013
    Manufacturer
    SIBONE
    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 INFO AND INVESTIGATION, AS WELL AS REVIEW OF THE SURGEON TRAINING MANUAL, CERTIFICATES OF COMPLIANCE AND FMEA, THE ROOT CAUSE IS IMPROPER SIZE SELECTION OF THE IFUSE IMPLANT.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A RIGHT SACROILIAC JOINT FUSION ON (B)(6) 2012 UTILIZING FOUR IFUSE IMPLANTS. IT IS THE SURGEON'S HABIT AND CUSTOM TO OBTAIN A POST-OPERATIVE CT SCAN. THE CT SCAN SHOWED THAT THE THIRD IMPLANT WAS SHORTER THAN DESIRED. THE PT HAD NO COMPLAINTS OF NUMBNESS, TINGLING, OR PAIN IN HER LOWER EXTREMITIES. ON (B)(6) 2012, THE SURGEON PERFORMED A REVISION SURGERY TO REMOVE THE THIRD IMPLANT (7 X 40 MM) AND REPLACED IT WITH A LONGER IMPLANT (7 X 50 MM). THE PT HAS NO PAIN OR NEUROLOGIC COMPLAINTS. THE PT HAD NO COMPLICATIONS AFTER THE ORIGINAL OR REVISION SURGERIES AND IS REPORTED AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34897 IFUSE IMPLANT SYSTEM PLATES, SCREWS, RODS OUR SIBONE

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention