BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 6856412 · Received September 11, 2017

    Report

    Report Number
    3007700286-2017-00091
    Event Type
    Injury
    Date Received
    September 11, 2017
    Date of Event
    August 14, 2017
    Report Date
    September 6, 2017
    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 FMEA, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS INSTALLING THE IMPLANT(S) TOO DEEP. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI NUMBERS: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7055-90, LOT# 493875, MFD. 04/10/2017, EXPIRES 2022-04, (B)(4); 2ND (SECOND): IFUSE IMPLANT, P/N 7060-90, LOT# 493925, MFD. 05/16/2017 EXPIRES 2022-05, (B)(4); 3RD (THIRD): IFUSE IMPLANT, P/N 7045-90, LOT# 493893, MFD. 04/30/2017, EXPIRES 2022-04, (B)(4); 4TH (INFERIOR): IFUSE IMPLANT, P/N 7045-90, LOT# 493924, MFD. 05/16/2017, EXPIRES 2022-05, (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD RIGHT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE FOUR IMPLANTS WERE PLACED. THE SURGEON LATER DETERMINED THAT THERE WERE BONE FRAGMENTS IN THE S1 NEUROFORAMEN CAUSED BY THE INSTALLATION AND SUBSEQUENT INTRAOPERATIVE ADJUSTMENT OF THE DEPTH OF THE IMPLANTS. IN (B)(6) 2017, THE SURGEON PERFORMED A FORAMINOTOMY AND REMOVED THE BONE FRAGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635307 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention