BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 3864468 · Received June 10, 2014

    Report

    Report Number
    3007700286-2014-00070
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 30, 2014
    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 GUIDE, IFU AND FMEA, THE MOST PROBABLE ROOT CAUSE IS LATE RECURRENCE OF SYMPTOMS. PART NUMBERS, LOT NUMBERS, MANUFACTURE DATES AND EXPIRATION DATES: IFUSE IMPLANT, P/N 7040-90, LOT# I0854, MANUFACTURED 12/04/13, EXPIRES 2018-11. IFUSE IMPLANT, P/N 7050-90, LOT# I0503, MANUFACTURED 07/03/13, EXPIRES 2018-03.

    Description of Event or Problem · 1

    IN (B)(6) 2014, THE SURGEON PERFORMED A LEFT SIDE IFUSE SI JOINT ARTHRODESIS ON THE PATIENT PLACING TWO IMPLANTS. THE PATIENT HAD COMPLETE RELIEF OF HER SYMPTOMS FOLLOWING THE SURGERY BUT SHE FELL TWO MONTHS LATER AND THE SYMPTOMS RETURNED. IN (B)(6) 2014, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE ADVANCED THE SECOND IMPLANT FURTHER ACROSS THE JOINT AND ADDED ONE ADDITIONAL IMPLANT. NO IMPLANTS WERE REMOVED. THE PATIENT IS DOING WELL AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340808 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention