BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 10295780 · Received July 20, 2020

    Report

    Report Number
    3007700286-2020-00055
    Event Type
    Injury
    Date Received
    July 20, 2020
    Date of Event
    June 29, 2020
    Report Date
    July 17, 2020
    Manufacturer
    SI-BONE, INC.
    Product Code
    OUR
    UDI-DI
    00851085007305
    PMA / PMN Number
    K190230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 FMEAS, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS USER ERROR; MALPOSITIONING OF THE INITIAL IMPLANT.

    Description of Event or Problem · 1

    THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2020 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED SI JOINT PAIN SYMPTOMS. THE SURGEON DETERMINED THAT THE CAUDAL POSITIONED IMPLANT WAS MALPOSITIONED AND NOT FULLY ACROSS THE SI JOINT. THREE WEEKS AFTER THE INITIAL PROCEDURE, THE SURGEON REMOVED THE CAUDAL POSITIONED IMPLANT. 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
    762823 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. 7035M-90 2691791 00851085007305

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other