BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 3864565 · Received June 10, 2014

    Report

    Report Number
    3007700286-2014-00076
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 29, 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 SURGICAL TECHNIQUE GUIDE, IFU, CERTIFICATES OF ANALYSIS AND FMEA, THERE IS NO EVIDENCE THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS A MALPOSITIONED IMPLANT. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES AND EXPIRATION DATES: IFUSE IMPLANT, P/N 7040-90, LOT# I0876, MANUFACTURED 01/27/14, EXPIRES 2018-12; IFUSE IMPLANT, P/N 7040-90, LOT# I0879, MANUFACTURED 12/16/13, EXPIRES 2018-12; IFUSE IMPLANT, P/N 7065-90, LOT# I0652, MANUFACTURED 05/29/13, EXPIRES 2018-05.

    Description of Event or Problem · 1

    IN (B)(6) 2014, THE SURGEON PERFORMED A RIGHT LEFT SIDE SI JOINT ARTHRODESIS ON THE PATIENT PLACING THREE IFUSE IMPLANTS. THE PATIENT BEGAN EXPERIENCING NEW ONSET RADICULAR PAIN APPROXIMATELY 36 HOURS POST-OP. A CT SCAN REVEALED THAT THE THIRD IMPLANT MAY HAVE BEEN IMPINGING ON THE NEUROFORAMEN. TWO DAYS LATER, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE THIRD IMPLANT AND REPLACED IT WITH A SHORTER IMPLANT USING THE SAME HOLE LEFT BY THE EXPLANT. NO OTHER IMPLANTS WERE ADJUSTED OR ADDED. THE PATIENT'S RADICULAR PAIN RESOLVED BY THE FOLLOWING MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340940 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention