BEUDAMED
    FDA Adverse Event Other Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 2864323 · Received December 6, 2012

    Report

    Report Number
    3007700286-2012-00074
    Event Type
    Other
    Date Received
    December 6, 2012
    Date of Event
    October 31, 2012
    Report Date
    December 6, 2012
    Manufacturer
    SIBONE INC.
    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 INFORMATION AND INVESTIGATION, AS WELL AS REVIEW OF THE SURGEON TRAINING MANUAL AND (B)(4), 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 PATIENT 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 PATIENT HAS NO PAIN OR NEUROLOGIC COMPLAINTS. THE PATIENT HAS DONE WELL SINCE THE REVISION SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention