BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 10168481 · Received June 18, 2020

    Report

    Report Number
    3007700286-2020-00047
    Event Type
    Injury
    Date Received
    June 18, 2020
    Date of Event
    May 28, 2020
    Report Date
    June 17, 2020
    Manufacturer
    SI-BONE, INC.
    Product Code
    OUR
    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 IFU, AND FMEAS, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. IT WAS THE SURGEON'S DECISION TO REMOVE THE IMPLANTS AT THE PATIENT'S REQUEST. IMPLANT PART NUMBERS AND GTINS: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7050-100, LOT# UNKNOWN, MFD. UNKNOWN, EXP. UNKNOWN, GTIN (B)(4). 2ND (MIDDLE): IFUSE IMPLANT, P/N 7040-100, LOT# UNKNOWN, MFD. UNKNOWN, EXP. UNKNOWN, GTIN (B)(4). 3RD (INFERIOR): IFUSE IMPLANT, P/N 7040-100, LOT# UNKNOWN, MFD. UNKNOWN, EXP. UNKNOWN, GTIN (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2018 WHERE THREE IMPLANTS WERE INSTALLED. THE PATIENT COMPLAINED OF NO PAIN RELIEF FOLLOWING THE INITIAL PROCEDURE AND WANTED THE IMPLANTS REMOVED. IN (B)(6) 2020, THE SURGEON REMOVED ALL THREE IMPLANTS. NO ADDITIONAL HARDWARE WAS INSTALLED. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635326 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 Other