BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 4252260 · Received November 14, 2014

    Report

    Report Number
    3007700286-2014-00119
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    November 3, 2014
    Report Date
    November 13, 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 CONFORMANCE AND FMEA, THERE IS NO EVIDENCE THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE FOR THE REVISION IS INSUFFICIENT SI JOINT FIXATION AND A MALPOSITIONED IMPLANT. PART, PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES AND EXPIRATION DATES: IFUSE IMPLANT, P/N 7035-90, LOT# 8175003938011, MANUFACTURED 09/01/12, EXPIRES 2015-10; IFUSE IMPLANT, P/N 7045-90, LOT# I0833, MANUFACTURED 10/14/13, EXPIRES 2018-09; IFUSE IMPLANT, P/N 7050-90, LOT# I0303, MANUFACTURED 04/04/13, EXPIRES 2018-01.

    Description of Event or Problem · 1

    IN (B)(6) 2013, THE PATIENT HAD A RIGHT SIDE SI JOINT FUSION WHERE THREE IFUSE IMPLANTS WERE PLACED. THE PATIENT LATER EXPERIENCED BACK PAIN. A CT SCAN REVEALED THAT AN IMPLANT MAY HAVE BEEN POSITIONED TOO POSTERIOR. IN (B)(6) 2014, A NEW SURGEON PERFORMED A REVISION SURGERY WHERE HE TRIED TO REMOVE THE IMPLANT BUT IT WAS SOLIDLY IN BONE AND COULD NOT BE REMOVED. HE INSTEAD ADDED TWO ADDITIONAL IMPLANTS TO HELP FIXATE THE SI JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738599 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention