BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 6697866 · Received July 10, 2017

    Report

    Report Number
    3007700286-2017-00061
    Event Type
    Injury
    Date Received
    July 10, 2017
    Date of Event
    June 19, 2017
    Report Date
    July 6, 2017
    Manufacturer
    SI-BONE, 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 ON THE INFORMATION PROVIDED, REVIEW OF THE SURGICAL TECHNIQUE MANUAL, IFU, CERTIFICATES OF ANALYSIS AND FMEA, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS IMPLANT LOOSENING. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI NUMBERS: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7055-90, LOT# 222224, MFD. 10/21/14, EXPIRES 2019-10, UDI (B)(4). 2ND (MIDDLE): IFUSE IMPLANT, P/N 7050-90, LOT# I0A27, MFD. 06/16/14, EXPIRES 2019-06, UDI (B)(4). 3RD (INFERIOR): IFUSE IMPLANT, P/N 7050-90, LOT# I0958, MFD. 02/18/14, EXPIRES 2019-02, UDI (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2015 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT CLAIMED TO STILL HAVE PAIN AFTER THE PROCEDURE. SUSPECTED LUCENCY WAS SEEN ON IMAGING WELL AFTER THE INITIAL SURGERY. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE IMPLANTS AND FILLED THE VOIDS WITH BONE GRAFT AND ADDED ADDITIONAL HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480226 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention