BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 5944856 · Received September 12, 2016

    Report

    Report Number
    3007700286-2016-00063
    Event Type
    Injury
    Date Received
    September 12, 2016
    Date of Event
    August 25, 2016
    Report Date
    September 12, 2016
    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 COULD NOT BE DETERMINED. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI NUMBERS: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7045-90, LOT# 363332, MFD. 05/27/15, EXPIRES 2020-05, (B)(4). 2ND (MIDDLE): IFUSE IMPLANT, P/N 7045-90, LOT# 363332, MFD. 05/27/15, EXPIRES 2020-05, (B)(4). 3RD (INFERIOR): IFUSE IMPLANT, P/N 7040-90, LOT# 353332, MFD. 05/29/15, EXPIRES 2020-05, (B)(4).

    Description of Event or Problem · 1

    IN (B)(6) 2015, THE PATIENT UNDERWENT A LEFT SIDE SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED. THE PATIENT REPORTED LEG PAIN SOMETIME AFTER THE PROCEDURE. POST-OP CT SCANS WERE INCONCLUSIVE AS TO WHETHER ANY OF THE IMPLANTS WERE IMPINGING ON ANY NERVES. THE SURGEON ATTEMPTED TO TREAT THE PAIN MEDICALLY BUT THE PAIN PERSISTED. THE SURGEON DECIDED TO PERFORM A REVISION SURGERY TO SEE IF THAT WOULD HELP THE PAIN SYMPTOMS. IN (B)(6) 2016 THE SURGEON PERFORMED A REVISION SURGERY WHERE ALL THREE IMPLANTS WERE BACKED OUT A FEW MILLIMETERS EACH BUT NOT REMOVED. THE SURGERY DID NOT RELIEVE THE PAIN COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594872 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention