BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 7219671 · Received January 25, 2018

    Report

    Report Number
    3007700286-2018-00004
    Event Type
    Injury
    Date Received
    January 25, 2018
    Date of Event
    January 13, 2018
    Report Date
    January 22, 2018
    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, AND FMEAS, THERE IS NO INDICATION OF DEVICE FAILURE AND NO INDICATION THAT THE DEVICE WAS OUT OF SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS IMPLANT LOOSENING. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI/GTIN NUMBERS: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7070-100, LOT NUMBER UNKNOWN, (B)(4). 2ND (MIDDLE): IFUSE IMPLANT, P/N 7040-100, LOT NUMBER UNKNOWN, (B)(4). 3RD (INFERIOR): IFUSE IMPLANT, P/N 7045-100, LOT NUMBER UNKNOWN, (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2014 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT CLAIMS NOT TO HAVE HAD PAIN RELIEF FOLLOWING THE INITIAL LEFT SIDE PROCEDURE. THE PATIENT HAD A PREVIOUS CONTRALATERAL, RIGHT SIDE, SI JOINT ARTHRODESIS PROCEDURE THAT IS DOING WELL. A DIFFERENT SURGEON THOUGHT THAT THE IMPLANTS MAY BE LOOSE. IN (B)(6) 2018, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED THE IMPLANTS. ALTHOUGH THE SURGEON SUSPECTED IMPLANT LOOSENING, THE REMOVAL PROCESS REQUIRED THE USE OF CHISELS TO REMOVE THE IMPLANTS. HE REPLACED THE EXPLANTS WITH LARGER IFUSE IMPLANTS IN THE CRANIAL AND CAUDAL POSITIONS. THE PATIENT IS "COMFORTABLE" FOLLOWING THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63386 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention