BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 4928590 · Received July 21, 2015

    Report

    Report Number
    3007700286-2015-00052
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    May 18, 2015
    Report Date
    July 17, 2015
    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 THERE IS NO EVIDENCE THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS RISK ASSOCIATED WITH SURGERY. PART NUMBERS: IFUSE IMPLANT, P/N 7040-100, IFUSE IMPLANT, P/N 7040-100, IFUSE IMPLANT, P/N 7045-100, IFUSE IMPLANT, P/N 7055-100.

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED A HEMATOMA FOLLOWING THE IFUSE PROCEDURE IN (B)(6) 2015. THE SURGEON PERFORMED A SECOND SURGERY WHERE HE EVACUATED THE HEMATOMA. THE PATIENT'S PAIN COMPLAINTS RESOLVED FOLLOWING THE PROCEDURE. NO IMPLANTS WERE ADJUSTED OR REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471351 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R