BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 4808965 · Received June 1, 2015

    Report

    Report Number
    3007700286-2015-00044
    Event Type
    Injury
    Date Received
    June 1, 2015
    Date of Event
    May 26, 2015
    Report Date
    May 29, 2015
    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 IMPLANTS IMPINGING ON THE NEUROFORAMEN. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES (IF AVAILABLE) AND EXPIRATION DATES: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7040-90, LOT# I0A21, MANUFACTURED 06/03/14, EXPIRES 2019-06. 2ND (MIDDLE): IFUSE IMPLANT, P/N 7045-90, LOT# I0A26, MANUFACTURED 09/09/14, EXPIRES 2019-06. 3RD (INFERIOR): IFUSE IMPLANT, P/N 7045-90, LOT# I0A26, MANUFACTURED 09/09/14, EXPIRES 2019-06.

    Description of Event or Problem · 1

    IN (B)(6) 2015, THE PATIENT UNDERWENT LEFT SIDE IFUSE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD LEG PAIN COMPLAINTS FOLLOWING THE SURGERY. SOME OF THE IMPLANTS MAY HAVE BEEN IMPINGING ON THE NEUROFORAMEN. IN (B)(6) 2015, THE SURGEON PERFORMED A REVISION SURGERY WHERE SHE BACKED OUT ALL OF THE IMPLANTS APPROXIMATELY FIVE MILLIMETERS EACH. THE PATIENT'S LEG PAIN COMPLAINTS COMPLETELY RESOLVED FOLLOWING THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352360 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention