BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFUSE IMPLANT SYSTEM

    MDR report key: 7631477 · Received June 22, 2018

    Report

    Report Number
    3007700286-2018-00050
    Event Type
    Injury
    Date Received
    June 22, 2018
    Date of Event
    June 12, 2018
    Report Date
    June 21, 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 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/GTIN NUMBERS: RIGHT - 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7045-100, LOT# 493582, MFD. 13 OCT 15, EXPIRES 2020-10-13, GTIN (B)(4). RIGHT - 2ND (MIDDLE): IFUSE IMPLANT, P/N 7040-100, LOT# 493436, MFD. 30 JUL 15, EXPIRES 2020-07-30, GTIN (B)(4). RIGHT - 3RD (INFERIOR): IFUSE IMPLANT, P/N 7030-100, LOT# 170787, MFD. 05 FEB 14, EXPIRES 2019-02-05, GTIN (B)(4). LEFT - 1ST (SUPERIOR): IFUSE IMPLANT, P/N 7045-100, LOT# 493582, MFD. 13 OCT 15, EXPIRES 2020-10-13, GTIN (B)(4). LEFT - 2ND (MIDDLE): IFUSE IMPLANT, P/N 7040-100, LOT# 493436, MFD. 30 JUL 15, EXPIRES 2020-07-30, GTIN (B)(4). LEFT - 3RD (INFERIOR): IFUSE IMPLANT, P/N 7040-100, LOT# 493436, MFD. 30 JUL 15, EXPIRES 2020-07-30, GTIN (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD STAGED BILATERAL SI JOINT ARTHRODESIS WHERE THREE IMPLANTS WERE PLACED ON EACH SIDE IN (B)(6) 2017. THE PATIENT LATER REPORTED TO A DIFFERENT SURGEON CLAIMING NO PAIN RELIEF AND REQUESTED THAT ALL THE SI JOINT IMPLANTS BE REMOVED. THE SURGEON DID NOT INDICATE THAT THE IMPLANTS WERE LOOSE OR MALPOSITIONED, BUT REMOVED THEM AT THE BEHEST OF THE PATIENT IN (B)(6) 2018. THE STATUS OF THE PATIENT FOLLOWING THE REVISION PROCEDURE IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472513 IFUSE IMPLANT SYSTEM ORTHOPEDIC ROD OUR SI-BONE, INC. SEE SECTION H.10 SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other