BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 7098060 · Received December 7, 2017

    Report

    Report Number
    3007700286-2017-00138
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    November 29, 2017
    Report Date
    December 5, 2017
    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 CONFORMANCE 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 IMPROPER IMPLANT SIZE SELECTION OR PLACING THE IMPLANTS TOO DEEP. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI/GTIN NUMBERS: 2ND (MIDDLE): IFUSE IMPLANT, P/N 7045-90, LOT# 7550002452005, MFD. 04/27/11, EXPIRES 2014-04, UDI (B)(4). 3RD (INFERIOR): IFUSE IMPLANT, P/N 7050-90, LOT# 7550002440005, MFD. 04/07/11, EXPIRES 2014-04, UDI (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD LEFT SIDE SI JOINT ARTHRODESIS IN (B)(6) 2011 WHERE THREE IMPLANTS WERE PLACED. THE PATIENT LATER PRESENTED TO A NEW SURGEON WITH PAIN COMPLAINTS. THE SURGEON THOUGHT THAT THE MIDDLE AND CAUDAL IMPLANTS WERE TOO CLOSE TO THE NEUROFORAMEN. IN (B)(6) 2017, THE SURGEON REMOVED THE MIDDLE AND CAUDAL IMPLANTS. THE STATUS OF THE PATIENT FOLLOWING THE REVISION SURGERY IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875872 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention