BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 3419127 · Received October 18, 2013

    Report

    Report Number
    3007700286-2013-00071
    Event Type
    Injury
    Date Received
    October 18, 2013
    Date of Event
    September 19, 2013
    Report Date
    October 18, 2013
    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 SURGEON TRAINING DIDACTIC, IFU, CERTIFICATES OF ANALYSIS AND FMEA, THE MOST LIKELY ROOT CAUSE COULD NOT BE DETERMINED. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES AND EXPIRATION DATES: P/N 7035-90, LOT# 7914003181006, MANUFACTURED 01/12/12, EXPIRES 2015-02; P/N 7040-90, LOT# 8047003363007, MANUFACTURED 05/0712, EXPIRES 2015-07; P/N 7045-90, LOT# 8078003696004, MANUFACTURED 06/18/12, EXPIRES 2015-08.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE SURGEON PERFORMED AN SI JOINT ARTHRODESIS UTILIZING THE IFUSE IMPLANT SYSTEM PLACING THREE IFUSE IMPLANTS. THE PATIENT HAD INCREASED RIGHT SI JOINT PAIN FROM TWO WEEKS TO TWO MONTHS POST-OP. A CT SCAN SHOWED A RIGHT ILIAC WING FRACTURE AND BILATERAL ALAR FRACTURES. PATIENT WAS TREATED FOR OSTEOPOROSIS. ANOTHER CT SCAN ON (B)(6) 2013 SHOWED THAT THE FRACTURES WERE HEALED BUT THE SI JOINT PAIN WAS STILL PRESENT. ON (B)(6) 2013, THE SURGEON PERFORMED AN IFUSE IMPLANT REVISION SURGERY WHERE HE ADDED AN ADDITIONAL THREE IFUSE IMPLANTS (7X40MM, 7X50MM AND 7X50MM) ANTERIOR TO THE EXISTING THREE IMPLANTS ON THE RIGHT SIDE. THE SURGERY WAS PERFORMED WITHOUT COMPLICATIONS THE PATIENT WAS SEEN BY THE SURGEON ON (B)(6) 2013 AND PER THE SURGEON WAS DOING ¿EXTRAORDINARILY WELL.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535097 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR