BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 6497735 · Received April 17, 2017

    Report

    Report Number
    3007700286-2017-00028
    Event Type
    Injury
    Date Received
    April 17, 2017
    Date of Event
    January 25, 2018
    Report Date
    February 12, 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

    THE PATIENT HAD CONTINUED PAIN FOLLOWING THE FIRST REVISION PROCEDURE IN (B)(6) 2017. THE SURGEON PERFORMED AN ADDITIONAL REVISION IN (B)(6) 2018 WHERE ALL IMPLANTS WERE REMOVED USING CHISELS AS THEY WERE ALL SOLIDLY FIXED IN BONE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI/GTIN NUMBERS: BILATERAL: LEFT SIDE 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7050-90, LOT# 493683, MFD. 06/09/16, EXPIRES 2021-06, UDI (B)(4). 2ND (MIDDLE): IFUSE IMPLANT, P/N 7050-90, LOT# 493784, MFD. 12/02/16, EXPIRES 2021-12, UDI (B)(4). 3RD (INFERIOR): IFUSE IMPLANT, P/N 7045-90, LOT# 493698, MFD. 06/20/16, EXPIRES 2021-06, UDI (B)(4). BILATERAL: RIGHT SIDE 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7045-90, LOT# 493738, MFD. 09/06/16, EXPIRES 2021-09, UDI (B)(4). 2ND (MIDDLE): IFUSE IMPLANT, P/N 7055-90, LOT# 493636, MFD. 02/02/17, EXPIRES 2022-02, UDI (B)(4), 3RD (INFERIOR): IFUSE IMPLANT, P/N 7055-90, LOT# 493562, MFD. 09/08/15, EXPIRES 2020-09, UDI (B)(4).

    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 IMPLANTS ENCROACHING ON THE NEUROFORAMEN. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI NUMBERS: LEFT SIDE: 2ND (MIDDLE): IFUSE IMPLANT, P/N 7050-90, LOT# 493784, MFD. 12/02/2016, EXPIRES 2021-12, (B)(4). RIGHT SIDE: 2ND (MIDDLE): IFUSE IMPLANT, P/N 7055-90, LOT# 493636, MFD. 02/02/2017, EXPIRES 2022-02, (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD BILATERAL SI JOINT ARTHRODESIS IN (B)(6) 2017 WHERE THREE IMPLANTS WERE PLACED ON EACH SIDE. THE PATIENT HAD INITIAL SI JOINT PAIN RELIEF FOLLOWING THE SURGERY BUT COMPLAINED OF NEW BILATERAL LEG PAIN. THE SURGEON DETERMINED THAT THE SECOND (MIDDLE) IMPLANTS ON EACH SIDE WERE ENCROACHING ON THE S1 FORAMEN. IN (B)(6) 2017, THE SURGEON PERFORMED A REVISION SURGERY TO ADJUST THE MIDDLE IMPLANTS ON EACH SIDE. HE FIRST ATTEMPTED TO BACK OUT THE RIGHT SIDE MIDDLE IMPLANT BUT IT WAS SOLIDLY FIXED IN BONE AND COULD NOT BE MOVED, SO HE LEFT IT IN PLACE. HE THEN PROCEEDED TO BACK OUT THE LEFT SIDE IMPLANT A FEW MILLIMETERS. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT YET KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280246 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention