BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 8772776 · Received July 9, 2019

    Report

    Report Number
    3007700286-2019-00079
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    June 11, 2019
    Report Date
    July 8, 2019
    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 FMEAS, 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. IT WAS THE SURGEON'S DECISION TO REMOVE THE IMPLANTS AT THE PATIENT'S REQUEST. PART NUMBERS, LOT NUMBERS, MANUFACTURING DATES, EXPIRATION DATES AND UDI/GTIN NUMBERS: INSTALLED IN JUNE 2014: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7045-90, LOT# I0901, MFD. 01/21/14, EXP. 2019-01-21, GTIN (B)(4). 2ND (SECOND): IFUSE IMPLANT, P/N 7040-90, LOT# I0854, MFD. 11/21/13, EXP. 2018-11-21, GTIN (B)(4). 3RD (INFERIOR): IFUSE IMPLANT, P/N 7030-90, LOT# I0289, MFD. 12/27/12, EXP. 2017-12-27, GTIN (B)(4). CONTRALATERAL SIDE INSTALLED IN (B)(6) 2014: 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7040-90, LOT# I0878, MFD. UNKNOWN, EXP. 2018-12, GTIN (B)(4). 2ND (SECOND): IFUSE IMPLANT, P/N 7035-90, LOT# I0858, MFD. 12/16/13, EXP. 2018-12-16, GTIN (B)(4). 3RD (INFERIOR): IFUSE IMPLANT, P/N 7030-90, LOT# 8175003938010, MFD. 10/11/12, EXP. 2015-10-11, GTIN (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD STAGED BILATERAL SI JOINT ARTHRODESIS WITH THE FIRST SIDE PERFORMED IN (B)(6) 2014 AND THE CONTRALATERAL SIDE ON (B)(6) 2014. THREE IMPLANTS WERE INSTALLED ON EACH OCCASION. THE PATIENT LATER COMPLAINED OF LEFT SIDE DISCOMFORT AND REQUESTED THAT THE LEFT SIDE IMPLANTS BE REMOVED. THE SURGEON DID NOT INDICATE THAT THE IMPLANTS WERE MALPOSITIONED OR LOOSE OR THAT THERE WAS ANY MEDICAL NEED TO REMOVE THEM. IN (B)(6) 2019, THE SURGEON PERFORMED A REVISION SURGERY WHERE HE REMOVED ALL THE LEFT SIDE IMPLANTS AND REPLACED THEM WITH TWO LARGER IMPLANTS OF THE SAME TYPE. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564548 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other