BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 12321460 · Received August 13, 2021

    Report

    Report Number
    3007700286-2021-00083
    Event Type
    Injury
    Date Received
    August 13, 2021
    Date of Event
    July 29, 2021
    Report Date
    August 10, 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 IMPLANT LATE LOOSENING.

    Description of Event or Problem · 1

    THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2015 WHERE TWO IMPLANTS WERE INSTALLED ON EACH SIDE. THE PATIENT HAD A PERIOD OF PAIN RELIEF BEFORE LATER REPORTED TO A DIFFERENT SURGEON WITH COMPLAINTS OF A RECURRENCE OF RIGHT SIDE SI JOINT PAIN. THE SURGEON DETERMINED POSSIBLE LOOSENING OF THE RIGHT SIDE CAUDAL POSITIONED IMPLANT. IN (B)(6) 2021, THE SURGEON PERFORMED A REVISION PROCEDURE WHERE HE REMOVED THE RIGHT SIDE CAUDAL POSITIONED IMPLANT USING CHISELS AS IT WAS SOLIDLY FIXED IN BONE AND FILLED THE VOID WITH BONE GRAFT. HE THEN INSTALLED TWO NEW IMPLANTS OF THE SAME TYPE IN MORE ANTERIOR POSITIONS TO HELP FIXATE THE SI JOINT. THE PREEXISTING RIGHT SIDE CRANIAL POSITIONED IMPLANT WAS NOT ADJUSTED OR REMOVED. THE PATIENT NOW HAS THREE IMPLANTS IN THEIR 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
    1215402 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other