BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 6752014 · Received July 28, 2017

    Report

    Report Number
    3007700286-2017-00069
    Event Type
    Injury
    Date Received
    July 28, 2017
    Date of Event
    July 14, 2017
    Report Date
    July 20, 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 EVIDENCE THAT THE IMPLANTS MALFUNCTIONED. 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 7045-100, LOT# I0786, MFD. 08/17/2013, EXPIRES 2018-08, (B)(4); 2ND (MIDDLE): IFUSE IMPLANT, P/N 7045-100, LOT# I0786, MFD. 08/17/2013, EXPIRES 2018-08, (B)(4); 3RD (INFERIOR): IFUSE IMPLANT, P/N 7055-100, LOT# I0788, MFD. 08/05/2013, EXPIRES 2018-08, (B)(4); ADDITIONAL: IFUSE IMPLANT, P/N 7055-100, LOT# 322222, MFD. 12/02/2014, EXPIRES 2019-12, (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 HAD PAIN RELIEF FOR SIX MONTHS BUT THEN HAD A RECURRENCE OF PAIN SYMPTOMS. AN ADDITIONAL IMPLANT WAS ADDED IN (B)(6) 2015. THE PATIENT LATER PRESENTED TO A NEW SURGEON WITH A RECURRENCE OF PAIN. THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED TWO IMPLANTS THAT WERE SOLIDLY FIXED IN BONE AND ADDED ADDITIONAL HARDWARE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531766 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention