BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 7660473 · Received July 3, 2018

    Report

    Report Number
    3007700286-2018-00056
    Event Type
    Injury
    Date Received
    July 3, 2018
    Date of Event
    June 24, 2018
    Report Date
    July 2, 2018
    Manufacturer
    SI-BONE, INC.
    Product Code
    OUR
    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 FMEAS, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE FOR THE INFECTION IS THE SURGICAL PROCEDURE. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI/GTIN NUMBERS: 1ST (SUPERIOR): IFUSE-3D IMPLANT, P/N 7060M-90, LOT# 2631451, MFD. 03/19/2018, EXP. 2023-03-19, (B)(4). 2ND (SECOND): IFUSE-3D IMPLANT, P/N 7050M-90, LOT# 2631351, MFD. 03/05/2018, EXP. 2023-03-05, (B)(4). 3RD (INFERIOR): IFUSE-3D IMPLANT, P/N 7060M-90, LOT# 2631451, MFD. 03/19/2018, EXP. 2023-03-19, (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF PAIN FOLLOWING THE PROCEDURE WHICH RESOLVED FOLLOWING TWO DAYS OF PAIN KILLERS. THE PATIENT LATER DEVELOPED WOUND DEHISCENCE AND AN E. FAECALIS INFECTION AT THE WOUND SITE WHICH WAS REPORTED APPROXIMATELY TWO WEEKS AFTER THE SURGICAL PROCEDURE. THE PATIENT IS BEING TREATED WITH ORAL ANTIBIOTICS. THE PATIENT HAS NOT REPORTED ANY SI JOINT PAIN. THE HAS BEEN NO FURTHER UPDATES ON THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501053 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other