BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 10684764 · Received October 15, 2020

    Report

    Report Number
    3007700286-2020-00092
    Event Type
    Injury
    Date Received
    October 15, 2020
    Date of Event
    October 1, 2020
    Report Date
    October 14, 2020
    Manufacturer
    SI-BONE, INC.
    Product Code
    OUR
    UDI-DI
    00859256003293
    PMA / PMN Number
    K190230
    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 CONFORMANCE 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 NON-UNION OF THE SI JOINT, POSSIBLY DUE TO INSUFFICIENT INITIAL FIXATION.

    Description of Event or Problem · 1

    THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED TO A DIFFERENT SURGEON WITH A RECURRENCE OF RIGHT SIDE SI JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED NON-UNION OF THE SI JOINT. IN (B)(6) 2020, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE SUPERIOR POSITIONED IMPLANT USING CHISELS. HE THEN INSTALLED A WIDER IMPLANT OF THE SAME TYPE IN THE EXPLANT VOID. HE THEN INSTALLED TWO ADDITIONAL INTO THE RIGHT SI JOINT. THE PREEXISTING MIDDLE AND INFERIOR POSITIONED IMPLANTS WERE NOT ADJUSTED OR REMOVED. THE PATIENT NOW HAS FIVE IMPLANTS IN HER RIGHT SI JOINT. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148068 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. 7045-90 493978 00859256003293

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other