BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 12425010 · Received September 3, 2021

    Report

    Report Number
    3007700286-2021-00087
    Event Type
    Injury
    Date Received
    September 3, 2021
    Date of Event
    August 5, 2021
    Report Date
    September 2, 2021
    Manufacturer
    SI-BONE, INC.
    Product Code
    OUR
    PMA / PMN Number
    K193524
    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 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 PSEUDARTHROSIS.

    Description of Event or Problem · 1

    THE PATIENT HAD A PREVIOUS XLIF (EXTREME LATERAL INTERBODY FUSION). THE PATIENT HAD LEFT SI JOINT ARTHRODESIS IN (B)(6) 2019 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT HAD SI JOINT PAIN RELIEF FOR MANY MONTHS BEFORE COMPLAINING OF A RECURRENCE OF SI-JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED PSEUDARTHROSIS AROUND THE SUPERIOR AND MIDDLE POSITIONED IFUSE IMPLANTS. IN (B)(6) 2021, THE SURGEON REMOVED THE SUPERIOR AND MIDDLE IMPLANTS USING CHISELS. HE THEN INSTALLED NEW HARDWARE INTO EACH OF THE EXPLANT VOIDS. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. NO OTHER PREEXISTING IMPLANTS WERE ADJUSTED OR REMOVED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322411 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other