BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 4219749 · Received November 3, 2014

    Report

    Report Number
    3007700286-2014-00115
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 31, 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 IS MALPOSITIONED IMPLANTS AND IMPROPER IMPLANT SIZE SELECTION. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES AND EXPIRATION DATES: IFUSE IMPLANT P/N 7050-100, LOT 170861, MANUFACTURED 20 SEP 2013, EXPIRES 2018-08; IFUSE IMPLANT P/N 7055-100, LOT 159784, MANUFACTURED 06 JUN 2013, EXPIRES 2018-06; IFUSE IMPLANT P/N 7055-100, LOT I0788, MANUFACTURED 26 FEB 2014, EXPIRES 2019-02.

    Description of Event or Problem · 1

    IN (B)(6) 2014, THE SURGEON PERFORMED A LEFT SIDE SI JOINT FUSION ON THE PATIENT PLACING THREE IFUSE IMPLANTS. THE PATIENT REPORTED PAIN FOLLOWING THE PROCEDURE. THE SURGEON DETERMINED THAT THE IMPLANTS WERE NOT IMPLANTED TO THE PROPER DEPTH. IN OCTOBER 2014, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE MOST SUPERIOR IMPLANT AND REPLACED IT WITH A LONGER IFUSE IMPLANT IN A DIFFERENT TRAJECTORY. HE THEN BACKED OUT EACH OF THE REMAINING TWO IMPLANTS A FEW MILLIMETERS. THE PATIENT IS DOING FINE AFTER THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703309 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention