BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 3864402 · Received June 10, 2014

    Report

    Report Number
    3007700286-2014-00069
    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 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 IMPROPER IMPLANT SIZE SELECTION. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES AND EXPIRATION DATES: IFUSE IMPLANT, P/N 7055-90, LOT# 8175003938015, MANUFACTURED 09/13/2012, EXPIRES 2015-10; IFUSE IMPLANT, P/N 7040-90, LOT# 8078003696003, MANUFACTURED 06/16/2012, EXPIRES 2015-08; IFUSE IMPLANT, P/N 7040-90, LOT# 148822, MANUFACTURED 11/30/2012, EXPIRES 2017-11.

    Description of Event or Problem · 1

    IN (B)(6) 2013, THE PATIENT HAD AN SI JOINT ARTHRODESIS WHERE THREE IFUSE IMPLANTS WERE PLACED. THE PATIENT LATER COMPLAINED ABOUT PAIN WHILE SITTING AND LYING DOWN ON THE SURGICAL SIDE. A DIFFERENT SURGEON PERFORMED A CT SCAN THAT SHOWED THAT THE SECOND IMPLANT WAS TEN MILLIMETERS TOO PROUD AND WAS RUBBING AGAINST THE MUSCLE CAUSING PAIN. IN (B)(6) 2014, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE IMPLANT THAT WAS TOO PROUD AND FILLED THE EXPLANT HOLE WITH BONE GRAFT. HE THEN ADDED A SHORTER IMPLANT IN A MORE ANTERIOR POSITION. THE PATIENT IS DOING WELL AND THE PAIN IS "GREATLY REDUCED AND IMPROVING" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340994 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention