BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 3765179 · Received April 22, 2014

    Report

    Report Number
    3007700286-2014-00056
    Event Type
    Injury
    Date Received
    April 22, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 22, 2014
    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 GUIDE, IFU, CERTIFICATES OF ANALYSIS AND FMEA, THE MOST PROBABLE ROOT CAUSE IS LATE RECURRENCE OF SYMPTOMS. PART NUMBERS, LOT NUMBERS, MANUFACTURE DATES AND EXPIRATION DATES: IFUSE IMPLANT, P/N 7035-90, LOT# I0491, MANUFACTURED 09/26/13, EXPIRES 2018-03; IFUSE IMPLANT, P/N 7045-90, LOT# I0385, MANUFACTURED 06/11/13, EXPIRES 2018-03; IFUSE IMPLANT, P/N 7060-90, LOT# I0651, MANUFACTURED 05/28/13, EXPIRES 2018-05.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE SURGEON PERFORMED A RIGHT SIDE IFUSE SI JOINT ARTHRODESIS ON THE PATIENT PLACING THREE IMPLANTS. THE PATIENT HAD INITIAL SYMPTOM RELIEF, BUT THE PAIN RETURNED. THE SURGEON THOUGHT AN IMPLANT MAY HAVE BEEN PLACED TOO POSTERIOR. ON (B)(6) 2014, THE SURGEON PERFORMED A SECOND SURGERY WHERE HE ADDED ONE IMPLANT ANTERIOR TO THE CAUDAL IMPLANT. NO IMPLANTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243165 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention