BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 9272217 · Received November 4, 2019

    Report

    Report Number
    3007700286-2019-00131
    Event Type
    Injury
    Date Received
    November 4, 2019
    Date of Event
    October 11, 2019
    Report Date
    October 29, 2019
    Manufacturer
    SI-BONE, INC.
    Product Code
    OUR
    PMA / PMN Number
    K190230
    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 IS USER ERROR: IMPROPER IMPLANT SIZE SELECTION, USING AN IMPLANT THAT WAS TOO LONG, OR INSTALLING THE IMPLANT TOO DEEP. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI/GTIN NUMBERS: 1ST (SUPERIOR): IFUSE-3D IMPLANT, P/N 7050M-90, LOT# 2591251, MFD. 06/13/17, EXP. 2022-06-13, GTIN (B)(4). 2ND (MIDDLE): IFUSE-3D IMPLANT, P/N 7055M-90, LOT# 2591263, MFD. 06/29/17, EXP. 2022-06-29, GTIN (B)(4). 3RD (INFERIOR): IFUSE-3D IMPLANT, P/N 7045M-90, LOT# 2591241, MFD. 06/13/17, EXP. 2022-06-13, GTIN (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT LATER REPORTED RADICULAR PAIN COMPLAINTS IN (B)(6) 2017. IT WAS LEARNED IN (B)(6) 2019 THAT THE PATIENT HAD AN UNREPORTED REVISION PROCEDURE WHERE TWO OF THE THREE IMPLANTS WERE REMOVED. THE REVISION DATE AND PERFORMING SURGEON ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065983 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention