BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 7270075 · Received February 14, 2018

    Report

    Report Number
    3007700286-2018-00020
    Event Type
    Injury
    Date Received
    February 14, 2018
    Date of Event
    February 1, 2018
    Report Date
    February 13, 2018
    Manufacturer
    SI-BONE, INC.
    Product Code
    OUR
    UDI-DI
    00859256003316
    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 MANUAL, IFU, CERTIFICATES OF ANALYSIS 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 IMPROPER IMPLANT SIZE SELECTION.

    Description of Event or Problem · 1

    THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD SIX MONTHS OF PAIN RELIEF BEFORE REPORTING A RECURRENCE OF SI JOINT PAIN. THE SURGEON DETERMINED THAT THE CRANIAL POSITIONED IMPLANT MAY HAVE BEEN TOO SHORT AND NOT OPTIMALLY POSITIONED ACROSS THE SI JOINT. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE CRANIAL POSITIONED IMPLANT USING CHISELS AND PACKED THE EXPLANT VOID WITH BONE GRAFT. HE THEN PLACED A NEW, LONGER, IFUSE IMPLANT PACKED WITH BONE GRAFT IN A NEW POSTERIOR-TO-ANTERIOR/INFERIOR-TO-SUPERIOR TRAJECTORY TO MORE FULLY CROSS AND FIXATE THE SI JOINT. NO OTHER 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
    114212 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. 7055-90 493845 00859256003316

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention