BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 4753208 · Received May 6, 2015

    Report

    Report Number
    3007700286-2015-00038
    Event Type
    Injury
    Date Received
    May 6, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 5, 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 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 PSEUDARTHROSIS OF THE SI JOINT. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES (IF AVAILABLE) AND EXPIRATION DATES: IFUSE IMPLANT, P/N 7040-90, LOT# 7628002533007, MANUFACTURED 06/10/11, EXPIRES 2014-06; IFUSE IMPLANT, P/N 7050-90, LOT# 7550002452006, MANUFACTURED 04/21/11, EXPIRES 2014-04; IFUSE IMPLANT, P/N 7045-90, LOT# 7550002452005, MANUFACTURED 04/05/11, EXPIRES 2014-04.

    Description of Event or Problem · 1

    IN (B)(6) 2011, THE PATIENT UNDERWENT RIGHT SIDE IFUSE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT HAD INITIAL PAIN RELIEF BUT LATER HAD A RECURRENCE OF PAIN SYMPTOMS. THE SURGEON BELIEVED HE SAW LUCENCY AROUND THE IMPLANTS. IN (B)(6) 2015, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED ALL OF THE EXISTING IMPLANTS AND REPLACED THEM WITH ILIOSACRAL SCREWS. THE CONDITION OF THE PATIENT FOLLOWING THE REVISION SURGERY IS NOT YET KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297234 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention