BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 3864491 · Received June 10, 2014

    Report

    Report Number
    3007700286-2014-00075
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 10, 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, CERTIFICATES OF ANALYSIS, IFU AND FMEA, THERE IS NO EVIDENCE THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS LATE RECURRENCE OF SYMPTOMS. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES AND EXPIRATION DATES: IFUSE IMPLANT, P/N 7040-90, LOT# 8004003235003, MANUFACTURED 02/06/12, EXPIRES 2015-04. IFUSE IMPLANT, P/N 4050-90, LOT# 7987003323007, MANUFACTURED 03/21/12, EXPIRES 2015-05 (X2).

    Description of Event or Problem · 1

    THE PATIENT HAD IFUSE SI JOINT ARTHRODESIS PERFORMED IN (B)(6) 2012 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT COMPLAINED OF SI JOINT PAIN FOR MONTHS FOLLOWING THE SURGERY. IN (B)(6) 2014, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED ONE IMPLANT AND REPLACED IT WITH A LARGER ONE AND ADDED AN ADDITIONAL IMPLANT TO HELP FIXATE THE JOINT. THE PATIENT IS RECUPERATING FOLLOWING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341380 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention