BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 5760210 · Received June 29, 2016

    Report

    Report Number
    3007700286-2016-00046
    Event Type
    Injury
    Date Received
    June 29, 2016
    Date of Event
    June 9, 2016
    Report Date
    June 23, 2016
    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 MALPOSITIONED IMPLANTS IMPINGING ON THE NERVE ROOT. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI NUMBERS: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7055-90, LOT# I0928, MFD. 01/27/14, EXPIRES 2019-01, (B)(4); 2ND (MIDDLE): IFUSE IMPLANT, P/N 7050-90, LOT# 223222, MFD. 12/18/14, EXPIRES 2019-12, (B)(4); 3RD (INFERIOR): IFUSE IMPLANT, P/N 7045-90, LOT# I0898, MFD. 12/23/13, EXPIRES 2018-12, (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD A RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2016 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF MILD LEG PAIN AFTER THE INITIAL SURGERY. THE SURGEON THOUGHT THAT THE IMPLANTS MAY HAVE BEEN IMPINGING ON THE NEUROFORAMEN CREATING BONE FRAGMENTS THAT WERE PRESSING AGAINST THE L5 NERVE ROOT AND CAUSING PAIN. IN (B)(6) 2016, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE FIRST AND THIRD IMPLANTS. THE PATIENT IS DOING WELL AND THERE HAVE BEEN NO FURTHER PAIN COMPLAINTS FOLLOWING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414457 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention